Heart shunt device put to the test in 750-Patient Sham-Controlled trial

NCT ID NCT05425459

Disease control Sponsor: Corvia Medical Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small device called the Corvia Atrial Shunt in 750 people with heart failure where the heart pumps normally but doesn't fill properly. The device creates a tiny passage between heart chambers to relieve pressure. Participants are randomly assigned to get the shunt or a sham procedure, and researchers track heart failure events and quality of life over 12 months.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Chronic symptomatic heart failure (HF) documented by the following: 1. Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND 2. New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND 3. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months 2. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics 3. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction \< 30% in the 5 years prior. 4. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following: 1. Left Atrial (LA) diameter \> 4 cm; or 2. Diastolic LA volume \> 50 or LA volume index \> 28 ml/m2 or 3. Lateral e' \< 10 cm/s; or 4. e' \< 8 cm/s; or 5. Site determined elevated pulmonary capillary wedge pressure (PCWP) with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25 millimeters of mercury (mm Hg), and greater than RAP by ≥ 5 mm Hg. 6. Resting RAP ≤ 14 mmHg 7. Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) \< 1.75 Wood units 8. Age ≥ 40 years old 9. Participant has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the Institutional Review Board (IRB) or Ethics Committee (EC) 10. Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams 11. Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator. Exclusion Criteria: 1. Advanced heart failure defined as one or more of the below: 1. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF 2. Cardiac index \< 2.0 L/min/m2 3. Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months 4. Patient is on the cardiac transplant waiting list. 2. Inability to perform 6-minute walk test (distance \< 50 meters), OR 6-minute walk test \> 600m 3. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain) 4. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following: 1. More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR 2. TAPSE \< 1.4 cm; OR 3. Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR 4. Ultrasound or clinical evidence of congestive hepatopathy; OR 5. Evidence of RV dysfunction defined by TTE as an RV fractional area change \< 35%. 5. Any implanted cardiac rhythm device 6. Structural heart repair aortic valve replacement (AVR) or mitral valve replacement (MVR) (surgical or percutaneous) within the past 12 months; planned valve intervention in the next 3 months, or presence of hemodynamically significant valve disease as assessed by the site cardiologist and defined as: 1. Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or \> mild Mitral Stenosis (MS); OR 2. Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR 3. Aortic valve disease ≥ 2+ aortic regurgitation (AR) or \> moderate aortic stenosis (AS) 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation 8. Participants with existing or surgically closed (with a patch) atrial septal defects. Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded 9. Myocardial Infarction (MI) and/or percutaneous cardiac intervention within past 3 months; Coronary Artery Bypass Graft (CABG) surgery in past 3 months or any planned cardiac interventions in the 3 months following enrollment. 10. Known clinically significant un-revascularized coronary artery disease, defined as: coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia 11. Known clinically significant untreated carotid artery stenosis likely to require intervention 12. Atrial fibrillation with resting heart rate (HR) \> 100 beats-per-minute (BPM) 13. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis) 14. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 15. Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy 16. Anemia with Hemoglobin \< 10 g/dl 17. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 \<1Liter 18. Resting arterial oxygen saturation \< 95% on room air, \<93% when residing at high altitude 19. Currently requiring dialysis; or estimated glomerular filtration rate eGFR \< 25ml/min/1.73 m2 by chronic kidney disease (CKD) CKD-Epi equation 20. Systolic blood pressure \> 170 mm Hg at screening 21. Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase 22. Participants on significant immunosuppressive treatment or on systemic steroid treatment 23. Life expectancy less than 12 months for known non-cardiovascular reasons 24. Known hypersensitivity to nickel or titanium 25. Women of childbearing potential 26. Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures 27. Body Mass Index (BMI) \> 45; BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely 28. Severe depression and/or anxiety 29. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational 30. In the opinion of the investigator, the Participant is not an appropriate candidate for the study.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Heart failure, diastolic

Contacts and locations

Locations

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States
Asklepios Clinic Altona Hamburg

Hamburg, 22763, Germany
Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States
Cardiovascular Institute (CVI) Research

Pittsburgh, Pennsylvania, 15212, United States
Christ Hospital

Cincinnati, Ohio, 45219, United States
Christiana Care Health Services

Newark, Delaware, 19718, United States
Cleveland Clinic Florida

Weston, Florida, 33331, United States
Cleveland Clinic OH

Cleveland, Ohio, 44195, United States
DRK Clinics Berlin Koepenick

Berlin, 12559, Germany
Endeavor Health-Northshore

Glenview, Illinois, 60026, United States
Georg-August Universität Gottingen Universitätsklinikum Göttingen Klinik für Kardiologie und Pneumologie

Göttingen, Germany
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Heart Center of Dresden

Dresden, 01307, Germany
Helios Kliniken Schwerin

Schwerin, 19049, Germany
Herzzentrum Leipzig - Universitätsklinik

Leipzig, 04289, Germany
Hospital Charité - University Medicine Berlin

Berlin, 10117, Germany
John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia
Kerckhoff Klinik

Bad Nauheim, Germany
LKH University Clinic

Graz, 8047, Austria
LSU Health Shreveport

Shreveport, Louisiana, 71103, United States
Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States
Marienkrankenhaus Hospital Hamburg

Hamburg, 22087, Germany
Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States
Medical University of South Carolina

Charleston, South Carolina, 29403, United States
Memorial Regional Hospital

Hollywood, Florida, 33021, United States
MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States
NCH Naples

Naples, Florida, 34102, United States
North Central Heart-Avera

Sioux Falls, South Dakota, 57108, United States
Northside Hospital Gwinnett Campus

Lawrenceville, Georgia, 30046, United States
Northwestern University

Chicago, Illinois, 60611, United States
OHSU Hospital

Portland, Oregon, 97239, United States
Ohio State University Wexner medical Center

Columbus, Ohio, 43210, United States
Onze-Lieve-Vrouwziekenhuis Aalst (OLV)

Aalst, B-9300, Belgium
Prince Charles Hospital

Chermside, Queensland, 4032, Australia
Scripps Clinic

La Jolla, California, 92037, United States
St. Francis Hospital (Heart Hospital)

Tulsa, Oklahoma, 74136, United States
St. Paul's Hospital Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada
St. Vincents Hospital

Darlinghurst, New South Wales, Australia
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
UK Duesseldorf

Düsseldorf, Germany
UMCG - Groningen

Groningen, Netherlands
UMass Memorial Hospital University Campus

Worcester, Massachusetts, 01655, United States
Ulm University Hospital

Ulm, 89081, Germany
Unfallkrankenhaus Berlin

Berlin, Germany
Unity Health Toronto St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada
University Heart Center Bad Krozingen

Bad Krozingen, 79189, Germany
University Heart Center Freiburg

Freiburg im Breisgau, Germany
University Hospital Cologne

Cologne, 50937, Germany
University Hospital Münster

Münster, 48149, Germany
University Hospital Schleswig-Holstein (UKSH) Luebeck

Lübeck, 23538, Germany
University Hospital Wurzburg

Würzburg, 97080, Germany
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Cincinatti Medical Center

Cincinnati, Ohio, 45219, United States
University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States
University of Virginia

Charlottesville, Virginia, 22908, United States
Vanderbilt University

Nashville, Tennessee, 37235, United States
Vivantes Clinic Friedrichshain Berlin

Berlin, 10249, Germany
Weill Cornell

New York, New York, 10065, United States
Wellstar Kennestone

Marietta, Georgia, 30060, United States
West Virginia Heart and Vascular

Morgantown, West Virginia, 26508, United States

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