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Heart FailureNCT03088033

REDUCE LAP-HF TRIAL II

A study testing IASD System II implant and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) in people with Heart Failure, run by Corvia Medical at 91 sites in 15 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure
What is being tested?
IASD System II implant 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
608 participants
Where
91 sitesin 15 countries
Study dates
1 Jun 2017to Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

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

SELECT INCLUSION CRITERIA

  • Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
  • Symptoms of HF requiring current treatment with diuretics for ≥ 30 days AND
  • NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
  • ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
  • Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months
  • Age ≥ 40 years old, LV ejection fraction (EF) ≥ 40% within the past 3 months, without previously documented EF <30% (within the past 3 years)
  • Elevated PCWP with a gradient compared to right atrial pressure (RAP), documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mmHg, and greater than RAP by ≥ 5 mmHg

SELECT EXCLUSION CRITERIA

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
  • Cardiac Resynchronization Therapy initiated within the past 6 months
  • Advanced heart failure defined as one or more of the below:
  • ACC/AHA/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 m), OR 6 minute walk test > 600m
  • History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
  • Presence of significant valve disease defined by the site cardiologist as:
  • Mitral valve regurgitation defined as grade ≥ 3+ MR
  • Tricuspid valve regurgitation defined as grade ≥ 2+ TR
  • Aortic valve disease defined as ≥ 2+ AR or > moderate AS
  • Known clinically significant untreated carotid artery stenosis likely to require intervention
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

Trial locations and contacts

91 sites in 15 countries.

91 sites in 15 countries

United States44 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 41809

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Christ Hospital Ohio Heart and Vascular Institute

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University College of Medicine

    Columbus, Ohio, 43210

  • Ohio Health

    Columbus, Ohio, 43214

  • Baylor University Medical Center, Dallas

    Dallas, Texas, 75246

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Evanston Northshore Healthcare

    Evanston, Illinois, 60201

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33307

  • Hackensack University Medical Center

    Hamilton, New Jersey, 08690

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • Kaiser Permanente San Diego

    La Jolla, California, 92120

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Vanderbilt University

    Nashville, Tennessee, 37242

  • Yale University

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94115

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Tallahassee Research Institute, Inc.

    Tallahassee, Florida, 33208

  • University of Arizona College of Medicine

    Tucson, Arizona, 85724

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Wake Forest

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany11 sites

  • Kerckhoff Klinik

    Bad Nauheim

  • Charite Universitatsmedizin Berlin

    Berlin

  • Unfallkrankenhaus Berlin

    Berlin

  • Universitatklinikum Duseldorf

    Düsseldorf

  • Heart Center Freiburg University

    Freiburg im Breisgau

  • Georg-August-Universitat

    Göttingen

  • Cardiologicum CRC

    Hamburg

  • UKE Hamburg

    Hamburg

  • University of Heidelberg

    Heidelberg

  • Heart Center of the University of Leipzig

    Leipzig

  • Klinikum der Universität Munchen

    Munich

Other trials in Germany

Japan9 sites

  • Kyushu University Hospital

    Fukuoka

  • The Hospital of Hyogo College of Medicine

    Hyōgo

  • Nara Medical University Hospital

    Nara

  • National Cerebral and Cardiovascular Center

    Osaka

  • Osaka University Hospital

    Osaka

  • Hokkaido University Hospital

    Sapporo, Hokkaido

  • The University of Tokyo Hospital

    Tokyo

  • Tottori University Hospital

    Tottori

  • Toyama University Hospital

    Toyama

Other trials in Japan

Australia6 sites

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • Concord Hospital

    Camperdown, New South Wales, 2050

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

  • St. Vincent Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

France6 sites

  • CHU de Dijon

    Dijon

  • CHU de Nantes

    Nantes

  • Hôpital Bichat

    Paris

  • Hôpital La Pitié Salpétrière

    Paris

  • CHU de Rennes

    Rennes

  • CHU de Rouen

    Rouen

Other trials in France

Netherlands4 sites

  • VU University Medical Center

    Amsterdam

  • UMC Groningen

    Groningen

  • Maastricht UMC Hart & Vaat Centrum

    Maastricht

  • St Antonius Ziekenhuis

    Nieuwegein

Other trials in Netherlands

Belgium2 sites

  • OLVZ Aalst

    Aalst

  • Az Sint-Jan Brugge

    Bruges

Other trials in Belgium

United Kingdom2 sites

  • Golden Jubilee Hospital

    Glasgow

  • Guys & St Thomas NHS Foundation Trust

    London

Other trials in United Kingdom

Austria1 site

  • Medizinische Universität Graz

    Graz

Other trials in Austria

Canada1 site

  • Hamilton Health Sciences

    Hamilton, Ontario

Other trials in Canada

Croatia1 site

  • University Hospital Center, Zagreb

    Zagreb

Other trials in Croatia

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Italy1 site

  • University of Milano

    Milan

Other trials in Italy

Poland1 site

  • Fourth Military Hospital

    Wroclaw

Other trials in Poland

Spain1 site

  • Hospital Clinic Barcelona

    Barcelona

Other trials in Spain

About this study

Official title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Read the detailed description

Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group.

All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization.

Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II 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.

Conditions
Heart Failure
Being tested
IASD System II implant, intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Medical subject headings
Heart Failure

What participants receive

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

  • IASD System II implantDevice

    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 NCT03088033
Study groupRoleWhat they receive
TreatmentExperimentalPatients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure.
Receives: Device: IASD System II implant
ControlSham comparatorPatients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
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 the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.

    Measured: Up to 24 months

Secondary outcomes (4)

  1. Composite safety endpoint defined as follows:

    1. Cardiovascular mortality
    2. Non-fatal, ischemic stroke
    3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min)
    4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery
    5. Thrombo-embolic complications (TIA, systemic embolization)
    6. Newly acquired persistent or permanent AF or atrial flutter through
    7. ≥30% increase in RV size/decrease in TAPSE

    Measured: 12 months

  2. Rate of heart failure admissions

    Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up

    Measured: Up to 24 months

  3. Change in NYHA Class

    Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months

    Measured: 12 months

  4. Change in Kansas City Cardiomyopathy Questionnaire

    Change in KCCQ score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.

    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 posted23 Mar 2017
  2. Study start1 Jun 2017
  3. Primary completion29 Jul 2021
  4. Study completionSep 2026 (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
608 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088033
Sponsor's protocol ID
1601
Status last verified
Feb 2023
First submitted
14 Mar 2017
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Doi S, Kazui S, Akashi N, Patel RB, Komtebedde J, Mylavarapu U, Swarup V, Winkler S, Backhaus SJ, Litwin SE, Mohan RC, Kawash R, Sverdlov AL, Chung ES, Kaye DM, Hoendermis E, Hummel SL, Cikes M, Hayward CS, Starling R, Gupta DK, Zirlik A, McKenzie S, Nair A, Rieth A, Cutlip DE, Solomon SD, van Veldhuisen DJ, Leon MB, Silvestry FE, Shah SJ, Borlaug BA. Heart Failure Duration, Cardiac Remodeling, Dysfunction, and Hemodynamic Severity in HFpEF and HFmrEF: Insights From REDUCE LAP-HF II. JACC Heart Fail. 2026 Jun 5:103167. doi: 10.1016/j.jchf.2026.103167. Online ahead of print.

    PubMed 42268170

  • Chaudhary RS, Hussain SMD, Wang YS, Komtebedde J, Hasenfuss G, Borlaug BA, Kaye DM, Cleland JGF, Leon MB, Shah SJ, van Veldhuisen DJ, Solomon SD, Cikes M, Cutlip DE. Expanded Definition of Worsening Heart Failure: Impact on Clinical Outcomes and Quality-of-Life Assessment. JACC Heart Fail. 2025 Sep;13(9):102571. doi: 10.1016/j.jchf.2025.102571. Epub 2025 Jul 25.

    PubMed 40714684

  • Litwin SE, Komtebedde J, Borlaug BA, Kaye DM, Hasenfubeta G, Kawash R, Hoendermis E, Hummel SL, Cikes M, Gustafsson F, Chung ES, Mohan RC, Sverdlov AL, Swarup V, Winkler S, Hayward CS, Bergmann MW, Bugger H, McKenzie S, Nair A, Rieth A, Burkhoff D, Cutlip DE, Solomon SD, van Veldhuisen DJ, Leon MB, Shah SJ. Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials. Am Heart J. 2024 Dec;278:106-116. doi: 10.1016/j.ahj.2024.08.014. Epub 2024 Sep 3.

    PubMed 39237070

  • Gustafsson F, Petrie MC, Komtebedde J, Swarup V, Winkler S, Hasenfuss G, Borlaug BA, Mohan RC, Flaherty JD, Sverdlov AL, Fail PS, Chung ES, Lurz P, Lilly S, Kaye DM, Cleland JGF, Cikes M, Leon MB, Cutlip DE, van Veldhuisen DJ, Solomon SD, Shah SJ. 2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF: Results From REDUCE LAP-HF II. JACC Heart Fail. 2024 Aug;12(8):1425-1438. doi: 10.1016/j.jchf.2024.04.011. Epub 2024 Jun 26.

    PubMed 38934964

  • Patel RB, Silvestry FE, Komtebedde J, Solomon SD, Hasenfuss G, Litwin SE, Borlaug BA, Price MJ, Kawash R, Hummel SL, Cutlip DE, Leon MB, van Veldhuisen DJ, Rieth AJ, McKenzie S, Bugger H, Mazurek JA, Kapadia SR, Vanderheyden M, Ky B, Shah SJ. Atrial Shunt Device Effects on Cardiac Structure and Function in Heart Failure With Preserved Ejection Fraction: The REDUCE LAP-HF II Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):507-522. doi: 10.1001/jamacardio.2024.0520.

    PubMed 38630494

  • Litwin SE, Komtebedde J, Seidler T, Borlaug BA, Winkler S, Solomon SD, Eicher JC, Mazimba S, Khawash R, Sverdlov AL, Hummel SL, Bugger H, Boenner F, Hoendermis E, Cikes M, Demers C, Silva G, van Empel V, Starling RC, Penicka M, Cutlip DE, Leon MB, Kitzman DW, van Veldhuisen DJ, Shah SJ; REDUCE LAP-HF Investigators and Research Staff. Obesity in heart failure with preserved ejection fraction: Insights from the REDUCE LAP-HF II trial. Eur J Heart Fail. 2024 Jan;26(1):177-189. doi: 10.1002/ejhf.3092. Epub 2023 Dec 7.

    PubMed 37989800

  • Patel RB, Reddy VY, Komtebedde J, Wegerich SW, Sekaric J, Swarup V, Walton A, Laurent G, Chetcuti S, Rademann M, Bergmann M, McKenzie S, Bugger H, Bruno RR, Herrmann HC, Nair A, Gupta DK, Lim S, Kapadia S, Gordon R, Vanderheyden M, Noel T, Bailey S, Gertz ZM, Trochu JN, Cutlip DE, Leon MB, Solomon SD, van Veldhuisen DJ, Auricchio A, Shah SJ. Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2023 Oct;11(10):1351-1362. doi: 10.1016/j.jchf.2023.05.024. Epub 2023 Jul 19.

    PubMed 37480877

  • Litwin SE, Komtebedde J, Hu M, Burkhoff D, Hasenfuss G, Borlaug BA, Solomon SD, Zile MR, Mohan RC, Khawash R, Sverdlov AL, Fail P, Chung ES, Kaye DM, Blair J, Eicher JC, Hummel SL, Zirlik A, Westenfeld R, Hayward C, Gorter TM, Demers C, Shetty R, Lewis G, Starling RC, Patel S, Gupta DK, Morsli H, Penicka M, Cikes M, Gustafsson F, Silvestry FE, Rowin EJ, Cutlip DE, Leon MB, Kitzman DW, Kleber FX, Shah SJ; REDUCE LAP-HF Investigators and Research Staff. Exercise-Induced Left Atrial Hypertension in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2023 Aug;11(8 Pt 2):1103-1117. doi: 10.1016/j.jchf.2023.01.030. Epub 2023 Mar 20.

    PubMed 36939661

  • 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 IASD System II implant and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) in people with Heart Failure, run by Corvia Medical at 91 sites in 15 countries.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Germany, Japan, Australia, France and 10 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?

Results are not available in the source record.

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 24 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 NCT03088033, which also lists 9 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 22 Feb 2023.

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REDUCE LAP-HF TRIAL II (NCT03088033) | AzTrials