Sponsor study identifier
interventional
750
7 countries
61
Study Start
November 17, 2022
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2022
Actual (reported)June 21, 2022
Actual (reported)November 17, 2022
Actual (reported)July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Up to 12 months
The incidence of cardiovascular mortality
Up to 12 months
The rate of time-to-cardiovascular mortality
Up to 12 months
The rate of major adverse cardiac periprocedural events
Through 30 days
The incidence of non-fatal, ischemic stroke
Through 12 months
The rate of new onset or worsening of kidney dysfunction
Through 12 months
Participants 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.
Participants 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.
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) for examination of the atrial septum and left atrium.
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
Scripps Clinic
La Jolla, California, 92037, United States
MemorialCare Long Beach Medical Center
Long Beach, California, 90806, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
NCH Naples
Naples, Florida, 34102, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
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.
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.
Sanjiv Shah, MD
Northwestern Memorial Hospital
Martin Leon, MD
Columbia University
First Submitted
June 13, 2022
First Posted
June 21, 2022
Study Start
November 17, 2022
Actual (reported)Primary Completion
July 2027
EstimatedMobile App for Heart Failure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Northside Hospital Gwinnett Campus
Lawrenceville, Georgia, 30046, United States
Wellstar Kennestone
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Endeavor Health-Northshore
Glenview, Illinois, 60026, United States
LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
UMass Memorial Hospital University Campus
Worcester, Massachusetts, 01655, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Weill Cornell
New York, New York, 10065, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinatti Medical Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic OH
Cleveland, Ohio, 44195, United States
Ohio State University Wexner medical Center
Columbus, Ohio, 43210, United States
St. Francis Hospital (Heart Hospital)
Tulsa, Oklahoma, 74136, United States
OHSU Hospital
Portland, Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Cardiovascular Institute (CVI) Research
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
North Central Heart-Avera
Sioux Falls, South Dakota, 57108, United States
Vanderbilt University
Nashville, Tennessee, 37235, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
West Virginia Heart and Vascular
Morgantown, West Virginia, 26508, United States
St. Vincents Hospital
Darlinghurst, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
LKH University Clinic
Graz, 8047, Austria
Onze-Lieve-Vrouwziekenhuis Aalst (OLV)
Aalst, B-9300, Belgium
St. Paul's Hospital Providence Health Care
Vancouver, British Columbia, V6Z 1Y6, Canada
Unity Health Toronto St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
University Heart Center Bad Krozingen
Bad Krozingen, 79189, Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Hospital Charité - University Medicine Berlin
Berlin, 10117, Germany
Vivantes Clinic Friedrichshain Berlin
Berlin, 10249, Germany
DRK Clinics Berlin Koepenick
Berlin, 12559, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
University Hospital Cologne
Cologne, 50937, Germany
Heart Center of Dresden
Dresden, 01307, Germany
UK Duesseldorf
Düsseldorf, Germany
University Heart Center Freiburg
Freiburg im Breisgau, Germany
Georg-August Universität Gottingen Universitätsklinikum Göttingen Klinik für Kardiologie und Pneumologie
Göttingen, Germany
Marienkrankenhaus Hospital Hamburg
Hamburg, 22087, Germany
Asklepios Clinic Altona Hamburg
Hamburg, 22763, Germany
Herzzentrum Leipzig - Universitätsklinik
Leipzig, 04289, Germany
University Hospital Schleswig-Holstein (UKSH) Luebeck
Lübeck, 23538, Germany
University Hospital Münster
Münster, 48149, Germany
Helios Kliniken Schwerin
Schwerin, 19049, Germany
Ulm University Hospital
Ulm, 89081, Germany
University Hospital Wurzburg
Würzburg, 97080, Germany
UMCG - Groningen
Groningen, Netherlands
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 18, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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