Clinical Trials

Saint Luke's Research strives to continuously improve the quality and value of health care as a national leader in clinical, translational, and outcomes research. Review our currently active studies listed by specialty, primary indication, or trial short name. For more information about a trial, reach out to the contact email listed.

Audiology

Hearing

Perimodiolar Implant
A pre-market, open-label feasibility, prospective, single-arm multicenter feasibility investigation of hearing performance using the Cl632 in adults with low-frequency residual hearing.
[email protected]
Robert Cullen, MD
Learn more about this study: NCT04741009 

Amyloidosis

CARS
Cardiac Amyloidosis Registry Study ("CARS")
[email protected]
Brett Sperry, MD
Learn more about this study: NCT05174338

DepleTTR-CM
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
[email protected]
Brett Sperry, MD
Learn more about this study: NCT06183931

PYP Pfizer
Quantitative assessment of technetium pyrophosphate washout in patients with light chain and transthyretin cardiac amyloidosis
[email protected]
Brett Sperry, MD

ACT-EARLY
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
[email protected]
Brett Sperry, MD
Learn more about this study: NCT06563895

MaesTTRo
A Non-interventional, Prospective, Multi-country Study Collecting Realworld Data on the Characteristics, Treatment Patterns, and Outcomes of Patients with Amyloid Transthyretin (ATTR) Amyloidosis
[email protected]
Brett Sperry, MD
Learn more about this study: NCT06465810

Aortic Stenosis

ENVISION
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement
[email protected]
Adnan Chhatriwalla, MD
Learn more about this study: NCT05932615

PROGRESS CAP
SAPIEN 3/SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA Moderate AS PROGRESS Trial Access
[email protected]
Adnan Chhatriwalla, MD
Learn more about this study: NCT04889872

Aortic Valve

PROTEMBO
Cerebral Protection in Transcatheter Aortic Valve Replacement – The PROTEMBO Trial
[email protected]
Adnan Chhatriwalla, MD
Learn more about this study: NCT05873816

SHIELD
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR (SHIELD)
[email protected] 
Adnan Chhatriwalla, MD
Learn more about this study: NCT06689839

RESTORE
RESTORE Study (REdo tranScatheter aortic valve replacement for Transcatheter aOrtic valve failuRE)
[email protected] 
Chetan Huded, MD
Learn more about this study: NCT06777368

Atrial Fibrillation

PACeS
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG
[email protected]
Keith Allen, MD
Learn more about this study: NCT04045665

Cardiometabolic

MARITIME-HF
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)
[email protected] 
Andrew Sauer, MD
Learn more about this study: NCT07037459

Cardiopulmonary Bypass

ARTEMIS
ARTEMIS: RAvulizumab to PRotect PaTients with Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
[email protected]
Sean McCarney, MD
Learn more about this study: NCT05746559

Cardiothoracic Surgery

CTSN – EMBOLIC
EMBOLIC PROTECTION IN PATIENTS UNDERGOING HIGHRISK VALVE SURGERY
[email protected]
Keith Allen, MD
Learn more about this study: NCT06027788

REDUCE
The Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the intercostal nerves Registry (REDUCE Registry)
[email protected]
Michael Gibson, MD
Learn more about this study: NCT05110989

Coronary Artery Disease

PCORI RECHARGE
REvascularization CHoices Among under-Represented Groups Evaluation (The RECHARGE Trial)
[email protected]
Adam Salisbury, MD
Learn more about this study: NCT06399705

PREVAIL
A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)
[email protected]
Steven Laster, MD
Learn more about this study: NCT06535854

FRACTURE
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease
[email protected]
Dmitri Baklanov, MD
Learn more about this study: NCT06181240

CV Surgery

2165_Gore_AAA 24-01_
Thoracoabdominal Branch Endoprosthesis Post-Approval Study
[email protected] 
Muzammil Aziz, MD
Learn more about this study: NCT06578741

Electrophysiology

Product Surveillance Registry
Product Surveillance Registry (PSR) Platform Base Protocol
[email protected]
Brian Ramza, MD
Learn more about this study: NCT01524276

PIPER-ICD
Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs
[email protected]
Daniel Steinhaus, MD

SIMPLAAFY
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
[email protected]
Chetan Huded, MD
Learn more about this study: NCT06521463

RAPTOR-CIED
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
[email protected]
Daniel Steinhaus, MD
Learn more about this study: NCT06937658

Heart Failure

AIM HIGHer
Assessment of Implantable CCM in the Heart FaIlure Group with Higher Ejection Fraction (AIM HIGHer)
[email protected]
Timothy Fendler, MD
Learn more about this study: NCT05064709

PROACTIVE-HF-2
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II -III Heart Failure Patients (PROACTIVE- HF-2 Trial)
[email protected]
Michael Nassif, MD
Learn more about this study: NCT05934487

REDEFINE-HF
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF)
[email protected]
Andrew Sauer, MD
Learn more about this study: NCT06008197

CONFIRMATION
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
[email protected]
Andrew Sauer, MD
Learn more about this study: NCT06024746

FINALITY
A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists
[email protected]
Andrew Sauer, MD
Learn more about this study: NCT06033950

ELEVATE HFpEF
Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction (ELEVATEHFpEF)
[email protected] 
Brian Ramza, MD
Learn more about this study: NCT06678841

COMET-HF
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of an oral HF therapy in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction
[email protected]
Andrew Kao, MD
Learn more about this study: NCT06736574

GenePHIT
A Phase 2, adaptive, double-blinded, placebo-controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure
[email protected]
Andrew Kao, MD
Learn more about this study: NCT05598333

TEAM-HF
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure
[email protected]
Timothy Fendler, MD
Learn more about this study: NCT06526195

RELIVE
RELIVE Trial- Randomized Evaluation of Less Invasive Ventricular Enhancement
[email protected]
Andrew Kao, MD
Learn more about this study: NCT06813820

Attralus
Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02
[email protected]
Brett Sperry, MD
Learn more about this study: NCT05951049

Interventional

PREVAIL
A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (Prevail Global)
[email protected]
Steven Laster, MD
Learn more about this study: NCT06535854

FRACTURE
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease
[email protected]
Dmitri Baklanov, MD
Learn more about this study: NCT06181240

Hypertension

US GPS
The Global Paradise® System US Post Approval Study
[email protected]
Steven Laster, MD
Learn more about this study: NCT06297291

Hypertrophic Cardiomyopathy

FOREST_HCM (Previously REDWOOD-OLE)
An Open-Label Study of CK­3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM)
[email protected]
Michael Nassif, MD
Learn more about this study: NCT04848506

CIRRUS-HCM
An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults with Hypertrophic Cardiomyopathy
[email protected]
Michael Nassif, MD
Learn more about this study: NCT06347159

Left Atrial Appendage

Conform
The CONFORM Pivotal Trial -An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
[email protected]
Chetan Huded, MD
Learn more about this study: NCT05147792

Mitral Regurgitation

ATLAS
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population
[email protected]
Adnan Chhatriwalla, MD
Learn more about this study: NCT06465745

Mitral Valve

PRIMARY
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds
[email protected]
Keith Allen, MD
Learn more about this study: NCT05051033

Percutaneous Coronary Intervention (PCI)

Cosira II
Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II (COSIRA-II)
[email protected]
Anthony Hart, MD
Learn more about this study: NCT05102019

Postural Orthostatic Tachycardia Syndrome (POTS)

POTS
A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients with Postural Orthostatic Tachycardia Syndrome
[email protected]
John Lee, MD
Learn more about this study: NCT06593600

Valvular Diseases

Explanted Heart Valve Registry
[email protected] 
Keith Allen, MD

Women's Cardiovascular Health

REBIRTH
Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH)
[email protected]
Anna Grodzinsky, MD
Learn more about this study: NCT05180773

HOPE
Heart Outcomes in Pregnancy Expectations (HOPE) for Mom and Baby
[email protected] 
Anna Grodzinsky, MD
Learn more about this study: NCT06517628

Pregnancy Complications Registry
Pregnancy Complications Leading to Cardiovascular Disease Outcomes Registry
[email protected]
Valerie Rader, MD

COOL
Monitoring outcomes for multidisciplinary care of women with cardiac disease in pregnancy: Creating a Cardio-Obstetrics Outcomes Log (COOL)
[email protected]
Anna Grodzinsky, MD

iSCAD
iSCAD Registry
[email protected]
Anna Grodzinsky, MD
Learn more about this study: NCT04496687

P-CARE
Peripartum Hypertension and Cardiac Assessment of Remodeling Evaluation (P-CARE)
[email protected]
Christopher DeZorzi, MD

Ventral Hernia

BRAVO II
A Prospective Study Evaluating the Clinical Outcomes of Ventral Hernias treated Robotically with OviTex® Reinforced Tissue Matrix
[email protected]
Geoffrey Slayden, MD
Learn more about this study: NCT04779918
 

Neurology

Ischemic Stroke

ARPEGGIO
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke
[email protected]
Coleman Martin, MD
Learn more about this study: NCT05585606

SATURN
Statins use in intracerebral hemorrhage patients
[email protected]
Karin Olds, MD
Learn more about this study: NCT03936361

SleepSMART
Sleep for Stroke Management And Recovery Trial
[email protected]
Karin Olds, MD
Learn more about this study: NCT03812653

Peripheral Neuropathy

Dogwood
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
[email protected]
Samuel Goldlust, MD
Learn more about this study: NCT05359133

Neurosurgery

3D Model
Evaluating the Impact of 3D Printed Spine Models on Patient Understanding and Satisfaction
[email protected]
Carlos Bagley, MD

Neuro-Oncology

Brain Cancer

MOAB
A multicenter trial to identify optimal atezolizumab biomarkers in the setting of recurrent gliobastoma. The MOAB Trial
[email protected]
Samuel Goldlust, MD
Learn more about this study: NCT06069726

Post-ICU Delirium

SPECTOR
Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: A Randomized Control Trial
[email protected]
Katie Callahan, RN

Advanced Solid Tumors

Scorpion
First-in-Human Study of STX-478, a H1047X Mutation-specific PI3Kα Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Advanced Solid Tumor Patients
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT05768139

Seagen-004
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06157892

Exelixis
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients with Advanced Solid Tumors
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT05932862

Breast Cancer

CAMBRIA-2
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
[email protected]
Whitney Hensing, MD
Learn more about this study: NCT05952557

ELAINE 3
Phase 3 open label study comparing efficacy and safety of the combination of lasofoxifene and abemaciclib to the combination of fulvestrant and abemaciclib for the treatment of adults with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT05696626

DYNASTY-Breast02
A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06018337

OptimICE-pCR
OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
[email protected]
Whitney Hensing, MD
Learn more about this study: NCT05812807

EmpowHER 303
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06435429

ALISCA-Breast1
A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06369285

FOURLIGHT-3
An Interventional, Open-label, Randomized, Multicenter Phase 3 study of PF-07220060 plus Letrozole compared to CDK4/6 Inhibitor plus Letrozole in participants over 18 years with Hormone Receptor (HR)-Positive, Her2-Negative Advanced/Metastatic Breast Cancer
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06760637

Merck_MK-2870-010
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cance
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06312176

EXActDNA-003
Breast Cancer Clinical Validation Study to Predict Recurrence of High-Risk Early Breast Cancer Treated With Neoadjuvant Therapy Using a Bespoke Circulating Tumor DNA Assay to Detect Molecular Residual Disease
[email protected]
Learn more about this study: NCT06401421
Whitney Hensing, MD

VIKTORIA-2
A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
[email protected]
Timothy Pluard, MD
Learn more about this study: NCT06757634

Colorectal Cancer

Cardiff CRDF-004
A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
[email protected] 
Marc Roth, MD
Learn more about this study: NCT06106308

AbbVie_M24-533
M24-533: A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with ABBV-400 in Subjects with Metastatic Colorectal Cancer– Feasibility Request
[email protected] 
Marc Roth, MD
Learn more about this study: NCT06820463

Gastrointestinal Cancer

CLARITY GC01
A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2, D9802C00001.
[email protected] 
Marc Roth, MD
Learn more about this study: NCT06346392

Glioblastoma

IVY-P3-24-021
Phase 3 trial for the PARP inhibitor, niraparib, plus XRT in newly-diagnosed, MGMT-unmethylated GBM
[email protected]
Samuel Goldlust, MD
Learn more about this study: NCT06388733

Hepatocellular Carcinoma (HCC)

Genentech
A Phase II, Open-Label, Multicohort, Multicenter Study in Patients with Hepatocellular Carcinoma and Child-Pugh B Cirrhosis.
[email protected] 
Marc Roth, MD
Learn more about this study: NCT06096779

Lung Cancer

Alchemist sub-study
A081801 Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO
[email protected] 
Thomas Bemis, MD
Learn more about this study: NCT04267848

Physical Therapy

Physical Activity in MBC
The effect of regular physical activity and virtual exercise intervention on physical functions, fatigue, mental health, and disease progression in Metastatic Breast Cancer (MBC)
[email protected] 
MacKenzie Messina

Lung Nodules

NIGHTINGALE
NIGHTINGALE: CliNIcal Utility of ManaGement of Patients witH CT and LDCT Identified Pulmonary Nodules UsinG the Percepta NasAL Swab ClassifiEr – with Familiarization
[email protected]
Matthew Aboudara, MD
Learn more about this study: NCT06426628

Pulmonary Embolism

PEERLESS II
RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
[email protected]
Jennifer Buckley, MD
Learn more about this study: NCT06055920