Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
608 participants
INTERVENTIONAL
2017-06-01
2026-09-30
Brief Summary
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REDUCE LAP-HFREF TRIAL
NCT03093961
Extended IASD Investigation: REDUCE LAP-HF IV
NCT04632160
REDUCE LAP-HF III Corvia Protocol 1701
NCT03191656
REDUCE LAP-HF RANDOMIZED TRIAL I
NCT02600234
REDUCE LAP-HF TRIAL
NCT01913613
Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Treatment
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.
IASD System II implant
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.
Control
Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
Interventions
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IASD System II implant
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)
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Corvia Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjiv Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Marty Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
University of Arizona College of Medicine
Tucson, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Kaiser Permanente San Diego
La Jolla, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Yale University
New Haven, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Evanston Northshore Healthcare
Evanston, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Hackensack University Medical Center
Hamilton, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
Christ Hospital Ohio Heart and Vascular Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University College of Medicine
Columbus, Ohio, United States
Ohio Health
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor University Medical Center, Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Concord Hospital
Camperdown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
St. Vincent Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Medizinische Universität Graz
Graz, , Austria
OLVZ Aalst
Aalst, , Belgium
Az Sint-Jan Brugge
Bruges, , Belgium
Hamilton Health Sciences
Hamilton, Ontario, Canada
University Hospital Center, Zagreb
Zagreb, , Croatia
Rigshospitalet
Copenhagen, , Denmark
CHU de Dijon
Dijon, , France
CHU de Nantes
Nantes, , France
Hôpital Bichat
Paris, , France
Hôpital La Pitié Salpétrière
Paris, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
Kerckhoff Klinik
Bad Nauheim, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Unfallkrankenhaus Berlin
Berlin, , Germany
Universitatklinikum Duseldorf
Düsseldorf, , Germany
Heart Center Freiburg University
Freiburg im Breisgau, , Germany
Georg-August-Universitat
Göttingen, , Germany
Cardiologicum CRC
Hamburg, , Germany
UKE Hamburg
Hamburg, , Germany
University of Heidelberg
Heidelberg, , Germany
Heart Center of the University of Leipzig
Leipzig, , Germany
Klinikum der Universität Munchen
Munich, , Germany
University of Milano
Milan, , Italy
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kyushu University Hospital
Fukuoka, , Japan
The Hospital of Hyogo College of Medicine
Hyōgo, , Japan
Nara Medical University Hospital
Nara, , Japan
National Cerebral and Cardiovascular Center
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Tottori University Hospital
Tottori, , Japan
Toyama University Hospital
Toyama, , Japan
VU University Medical Center
Amsterdam, , Netherlands
UMC Groningen
Groningen, , Netherlands
Maastricht UMC Hart & Vaat Centrum
Maastricht, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Fourth Military Hospital
Wroclaw, , Poland
Hospital Clinic Barcelona
Barcelona, , Spain
Golden Jubilee Hospital
Glasgow, , United Kingdom
Guys & St Thomas NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1601
Identifier Type: -
Identifier Source: org_study_id
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