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Heart FailureNCT05425459

RESPONDER-HF Trial

A study testing Corvia Atrial Shunt System / IASD System II and Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) in people with Heart Failure and Heart Failure, Diastolic, run by Corvia Medical at 61 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure, Heart Failure, Diastolic
What is being tested?
Corvia Atrial Shunt System / IASD System II and Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
750 participants
Where
61 sitesin 7 countries
Study dates
17 Nov 2022to Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic symptomatic heart failure (HF) documented by the following:
  • Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
  • New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
  • ≥ 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
  • 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
  • Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction < 30% in the 5 years prior.
Show all 18Show fewer
  • Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
  • Left Atrial (LA) diameter > 4 cm; or
  • Diastolic LA volume > 50 or LA volume index > 28 ml/m2 or
  • Lateral e' < 10 cm/s; or
  • e' < 8 cm/s; or
  • 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.
  • Resting RAP ≤ 14 mmHg
  • Site determined hemodynamic evidence of peak exercise pulmonary vascular resistance (PVR) < 1.75 Wood units
  • Age ≥ 40 years old
  • 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)
  • Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
  • Transseptal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator.

Who cannot join

  • Advanced heart failure defined as one or more of the below:
  • ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF
  • Cardiac index < 2.0 L/min/m2
  • Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
  • Patient is on the cardiac transplant waiting list.
  • Inability to perform 6-minute walk test (distance < 50 meters), OR 6-minute walk test > 600m
Show all 42Show fewer
  • 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)
  • Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:
  • More than mild right ventricular (RV) dysfunction as estimated by transthoracic echocardiogram (TTE); OR
  • TAPSE < 1.4 cm; OR
  • Right ventricular (RV) size ≥ left ventricular (LV) size as estimated by TTE; OR
  • Ultrasound or clinical evidence of congestive hepatopathy; OR
  • Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%.
  • Any implanted cardiac rhythm device
  • 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:
  • Mitral valve disease grade ≥ 3+ mitral regurgitation (MR) or > mild Mitral Stenosis (MS); OR
  • Tricuspid valve (TR) regurgitation grade ≥ 2+ TR; OR
  • Aortic valve disease ≥ 2+ aortic regurgitation (AR) or > moderate aortic stenosis (AS)
  • Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
  • 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
  • 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.
  • Known clinically significant un-revascularized coronary artery disease, defined as: coronary artery stenosis with angina or other evidence of ongoing active coronary ischemia
  • Known clinically significant untreated carotid artery stenosis likely to require intervention
  • Atrial fibrillation with resting heart rate (HR) > 100 beats-per-minute (BPM)
  • Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  • Participant is contraindicated to receive either dual antiplatelet therapy, or an oral anticoagulant; or has a documented coagulopathy
  • Anemia with Hemoglobin < 10 g/dl
  • Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as forced expiratory volume (FEV)1 <1Liter
  • Resting arterial oxygen saturation < 95% on room air, <93% when residing at high altitude
  • Currently requiring dialysis; or estimated glomerular filtration rate eGFR < 25ml/min/1.73 m2 by chronic kidney disease (CKD) CKD-Epi equation
  • Systolic blood pressure > 170 mm Hg at screening
  • Significant hepatic impairment defined as 3 times upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
  • Participants on significant immunosuppressive treatment or on systemic steroid treatment
  • Life expectancy less than 12 months for known non-cardiovascular reasons
  • Known hypersensitivity to nickel or titanium
  • Women of childbearing potential
  • Severe obstructive sleep apnea not treated with continuous positive airway pressure (CPAP) or other measures
  • Body Mass Index (BMI) > 45; BMI 40 - 45 is also excluded unless in the opinion of the investigator, vascular access can be obtained safely
  • Severe depression and/or anxiety
  • 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
  • In the opinion of the investigator, the Participant is not an appropriate candidate for the study.

Trial locations and contacts

61 sites in 7 countries.

61 sites in 7 countries

United States33 sites

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinatti Medical Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic OH

    Cleveland, Ohio, 44195

  • Ohio State University Wexner medical Center

    Columbus, Ohio, 43210

  • Endeavor Health-Northshore

    Glenview, Illinois, 60026

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • Northside Hospital Gwinnett Campus

    Lawrenceville, Georgia, 30046

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90806

  • Wellstar Kennestone

    Marietta, Georgia, 30060

  • West Virginia Heart and Vascular

    Morgantown, West Virginia, 26508

  • NCH Naples

    Naples, Florida, 34102

  • Vanderbilt University

    Nashville, Tennessee, 37235

  • Weill Cornell

    New York, New York, 10065

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • Cardiovascular Institute (CVI) Research

    Pittsburgh, Pennsylvania, 15212

  • OHSU Hospital

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • LSU Health Shreveport

    Shreveport, Louisiana, 71103

  • North Central Heart-Avera

    Sioux Falls, South Dakota, 57108

  • St. Francis Hospital (Heart Hospital)

    Tulsa, Oklahoma, 74136

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • UMass Memorial Hospital University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Germany19 sites

  • University Heart Center Bad Krozingen

    Bad Krozingen, 79189

  • Kerckhoff Klinik

    Bad Nauheim

  • Hospital Charité - University Medicine Berlin

    Berlin, 10117

  • Vivantes Clinic Friedrichshain Berlin

    Berlin, 10249

  • DRK Clinics Berlin Koepenick

    Berlin, 12559

  • Unfallkrankenhaus Berlin

    Berlin

  • University Hospital Cologne

    Cologne, 50937

  • Heart Center of Dresden

    Dresden, 01307

  • UK Duesseldorf

    Düsseldorf

  • University Heart Center Freiburg

    Freiburg im Breisgau

  • Georg-August Universität Gottingen Universitätsklinikum Göttingen Klinik für Kardiologie und Pneumologie

    Göttingen

  • Marienkrankenhaus Hospital Hamburg

    Hamburg, 22087

  • Asklepios Clinic Altona Hamburg

    Hamburg, 22763

  • Herzzentrum Leipzig - Universitätsklinik

    Leipzig, 04289

  • University Hospital Schleswig-Holstein (UKSH) Luebeck

    Lübeck, 23538

  • University Hospital Münster

    Münster, 48149

  • Helios Kliniken Schwerin

    Schwerin, 19049

  • Ulm University Hospital

    Ulm, 89081

  • University Hospital Wurzburg

    Würzburg, 97080

Other trials in Germany

Australia4 sites

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • St. Vincents Hospital

    Darlinghurst, New South Wales

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

Other trials in Australia

Canada2 sites

  • Unity Health Toronto St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St. Paul's Hospital Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Austria1 site

  • LKH University Clinic

    Graz, 8047

Other trials in Austria

Belgium1 site

  • Onze-Lieve-Vrouwziekenhuis Aalst (OLV)

    Aalst, B-9300

Other trials in Belgium

Netherlands1 site

  • UMCG - Groningen

    Groningen

Other trials in Netherlands

About this study

Official title: Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201)

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

Read the detailed description

Following supine bicycle exercise hemodynamic assessment to verify eligibility, patients are sedated then randomized to the treatment or control group. Patients in both arms will undergo placement of femoral venous access sheath.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.

Patients will be evaluated at pre-specified time intervals and followed for 5 years.

All patients will be unblinded after the 24 month follow up visit.

Being tested
Corvia Atrial Shunt System / IASD System II, Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Keywords
Heart failure with preserved ejection fraction (HFpEF), Heart failure with midrange ejection fraction (HFmrEF), Interatrial Shunt
Medical subject headings
Heart Failure, Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corvia Atrial Shunt System / IASD System IIDevice

    The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.

  • Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)Other

    Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.

Study groups in NCT05425459
Study groupRoleWhat they receive
TreatmentExperimentalParticipants randomized to the treatment arm will undergo a fluoroscopic and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and InterAtrial Shunt Device (IASD) System II implant procedure.
Receives: Device: Corvia Atrial Shunt System / IASD System II
ControlSham comparatorParticipants randomized to the control arm will undergo fluoroscopy and intracardiac echocardiography from the femoral vein or transesophageal echocardiography, for examination of the atrial septum and left atrial appendage.
Receives: Other: Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Primary Endpoint

    The primary endpoint is a composite of heart failure event rates and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months.

    Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health.

    Measured: Up to 12 months

Secondary outcomes (11)

  1. The incidence of cardiovascular mortality

    The incidence of cardiovascular mortality through 12 months.

    Measured: Up to 12 months

  2. The rate of time-to-cardiovascular mortality

    Time-to-cardiovascular mortality through 12 months.

    Measured: Up to 12 months

  3. The rate of major adverse cardiac periprocedural events

    Major adverse cardiac periprocedural events through 30 days defined as:

    1. Cardiac death
    2. Myocardial infarction
    3. Cardiac tamponade
    4. Emergency cardiac surgery.

    Measured: Through 30 days

  4. The incidence of non-fatal, ischemic stroke

    Incidence of non-fatal, ischemic stroke

    Measured: Through 12 months

  5. The rate of new onset or worsening of kidney dysfunction

    New onset or worsening of kidney dysfunction (defined as estimated glomerular filtration rate (eGFR) decrease of > 20 ml/min/1.73 m2) through 12 months

    Measured: Through 12 months

  6. The incidence of thrombo-embolic complications including transient ischaemic attack (TIA) and systemic embolization)

    The incidence of thrombo-embolic complications (TIA and systemic embolization) through 12 months

    Measured: Through 12 months

  7. The incidence of newly acquired persistent or permanent atrial fibrillation (AF) or atrial flutter

    The incidence of newly acquired persistent or permanent AF or atrial flutter

    Measured: Through 12 months

  8. The incidence of participants with a ≥30% decrease in Tricuspid Annular Plane Systolic Excursion (TAPSE)

    The incidence of participants with a ≥30% decrease Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Measured: Through 12 months

  9. The rate of heart failure (HF) admissions

    Total rate (first plus recurrent) per patient year of heart failure (HF) admissions or healthcare facility visits for intravenous diuresis or urgent visits with intensification of oral diuresis for HF through 24 months, analyzed when the last randomized participant completes 12 months follow-up.

    Measured: Through 24 months

  10. The change in New York Heart Association (NYHA) Class

    Change in NYHA functional Class between baseline and 12 months

    Measured: 12 months

  11. The change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

    Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score between baseline and 12 months, categorized as proportion of patients with changes of ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25 points. Responses are given on a Likert scale that for each individual item is scored on a scale of 0-100 with higher scores indicating better health

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start17 Nov 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425459
Sponsor's protocol ID
2201
Status last verified
Feb 2026
First submitted
13 Jun 2022
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Borlaug BA, Blair J, Bergmann MW, Bugger H, Burkhoff D, Bruch L, Celermajer DS, Claggett B, Cleland JGF, Cutlip DE, Dauber I, Eicher JC, Gao Q, Gorter TM, Gustafsson F, Hayward C, van der Heyden J, Hasenfuss G, Hummel SL, Kaye DM, Komtebedde J, Massaro JM, Mazurek JA, McKenzie S, Mehta SR, Petrie MC, Post MC, Nair A, Rieth A, Silvestry FE, Solomon SD, Trochu JN, Van Veldhuisen DJ, Westenfeld R, Leon MB, Shah SJ; REDUCE LAP-HF-II Investigators. Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure. Circulation. 2022 May 24;145(21):1592-1604. doi: 10.1161/CIRCULATIONAHA.122.059486. Epub 2022 Mar 31.

    PubMed 35354306

  • Shah SJ, Borlaug BA, Chung ES, Cutlip DE, Debonnaire P, Fail PS, Gao Q, Hasenfuss G, Kahwash R, Kaye DM, Litwin SE, Lurz P, Massaro JM, Mohan RC, Ricciardi MJ, Solomon SD, Sverdlov AL, Swarup V, van Veldhuisen DJ, Winkler S, Leon MB; REDUCE LAP-HF II investigators. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022 Mar 19;399(10330):1130-1140. doi: 10.1016/S0140-6736(22)00016-2. Epub 2022 Feb 1.

    PubMed 35120593

Questions about this trial

What is this clinical trial studying?

A study testing Corvia Atrial Shunt System / IASD System II and Intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) in people with Heart Failure and Heart Failure, Diastolic, run by Corvia Medical at 61 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Germany, Australia, Canada, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Primary Endpoint (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425459, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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