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REDUCE LAP-HF TRIAL II

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IASD System II implant
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Sponsored by
Corvia Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Cardiovascular Research Center
  • University of Arizona College of Medicine
  • Scripps Clinic
  • Kaiser Permanente San Diego
  • Kaiser Permanente San Francisco Medical Center
  • South Denver Cardiology Associates
  • Yale University
  • Medstar Washington Hospital Center
  • Holy Cross Hospital
  • Sarasota Memorial Hospital
  • Tallahassee Research Institute, Inc.
  • Cleveland Clinic Florida
  • Northwestern University
  • University of Chicago Medical Center
  • Evanston Northshore Healthcare
  • Cardiovascular Institute of the South
  • Ochsner Clinic Foundation
  • Tufts New England Medical Center
  • Massachusetts General Hospital
  • University of Michigan Health System
  • Minneapolis Heart Institute Foundation
  • Mayo Clinic
  • St. Louis Heart and Vascular
  • Hackensack University Medical Center
  • Morristown Memorial Hospital
  • Duke University Medical Center
  • Wake Forest
  • Christ Hospital Ohio Heart and Vascular Institute
  • Cleveland Clinic
  • Ohio State University College of Medicine
  • Ohio Health
  • Lancaster General Hospital
  • University of Pennsylvania
  • UPMC Presbyterian Hospital
  • Medical University of South Carolina
  • Vanderbilt University
  • Baylor University Medical Center, Dallas
  • Baylor College of Medicine
  • Houston Methodist Hospital
  • University of Texas Health Science Center at San Antonio
  • Intermountain Medical Center
  • University of Utah Medical Center
  • University of Virginia
  • Virginia Commonwealth University Medical Center
  • Concord Hospital
  • Royal Prince Alfred Hospital
  • John Hunter Hospital
  • St. Vincent Hospital
  • The Prince Charles Hospital
  • The Alfred Hospital
  • Medizinische Universität Graz
  • OLVZ Aalst
  • Az Sint-Jan Brugge
  • Hamilton Health Sciences
  • University Hospital Center, Zagreb
  • Rigshospitalet
  • CHU de Dijon
  • CHU de Nantes
  • Hôpital Bichat
  • Hôpital La Pitié Salpétrière
  • CHU de Rennes
  • CHU de Rouen
  • Kerckhoff Klinik
  • Charite Universitatsmedizin Berlin
  • Unfallkrankenhaus Berlin
  • Universitatklinikum Duseldorf
  • Heart Center Freiburg University
  • Georg-August-Universitat
  • Cardiologicum CRC
  • UKE Hamburg
  • University of Heidelberg
  • Heart Center of the University of Leipzig
  • Klinikum der Universität Munchen
  • University of Milano
  • Hokkaido University Hospital
  • Kyushu University Hospital
  • The Hospital of Hyogo College of Medicine
  • Nara Medical University Hospital
  • National Cerebral and Cardiovascular Center
  • Osaka University Hospital
  • The University of Tokyo Hospital
  • Tottori University Hospital
  • Toyama University Hospital
  • VU University Medical Center
  • UMC Groningen
  • Maastricht UMC Hart & Vaat Centrum
  • St Antonius Ziekenhuis
  • Fourth Military Hospital
  • Hospital Clinic Barcelona
  • Golden Jubilee Hospital
  • Guys & St Thomas NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Composite safety endpoint defined as follows:
Cardiovascular mortality Non-fatal, ischemic stroke New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery Thrombo-embolic complications (TIA, systemic embolization) Newly acquired persistent or permanent AF or atrial flutter through ≥30% increase in RV size/decrease in TAPSE
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
Change in NYHA Class
Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
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.

Full Information

First Posted
March 14, 2017
Last Updated
February 21, 2023
Sponsor
Corvia Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03088033
Brief Title
REDUCE LAP-HF TRIAL II
Official Title
A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvia Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
608 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Intervention Type
Device
Intervention Name(s)
IASD System II implant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Intervention Description
intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
Primary Outcome Measure Information:
Title
Composite Primary Endpoint
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Composite safety endpoint defined as follows:
Description
Cardiovascular mortality Non-fatal, ischemic stroke New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery Thrombo-embolic complications (TIA, systemic embolization) Newly acquired persistent or permanent AF or atrial flutter through ≥30% increase in RV size/decrease in TAPSE
Time Frame
12 months
Title
Rate of heart failure admissions
Description
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
Time Frame
Up to 24 months
Title
Change in NYHA Class
Description
Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
Time Frame
12 months
Title
Change in Kansas City Cardiomyopathy Questionnaire
Description
Change in KCCQ score between baseline and 12 months, categorized as ≤0, >0 - 5, >5 - 10, >10 - 15, >15 - 20, >20 - 25, >25.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Shah, MD
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marty Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cardiovascular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of Arizona College of Medicine
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kaiser Permanente San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Kaiser Permanente San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33307
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tallahassee Research Institute, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
33208
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Evanston Northshore Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
41809
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Louis Heart and Vascular
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Hackensack University Medical Center
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Christ Hospital Ohio Heart and Vascular Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37242
Country
United States
Facility Name
Baylor University Medical Center, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Concord Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
St. Vincent Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
OLVZ Aalst
City
Aalst
Country
Belgium
Facility Name
Az Sint-Jan Brugge
City
Brugge
Country
Belgium
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
University Hospital Center, Zagreb
City
Zagreb
Country
Croatia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Hôpital Bichat
City
Paris
Country
France
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
Country
France
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Universitatklinikum Duseldorf
City
Dusseldorf
Country
Germany
Facility Name
Heart Center Freiburg University
City
Freiburg
Country
Germany
Facility Name
Georg-August-Universitat
City
Gottingen
Country
Germany
Facility Name
Cardiologicum CRC
City
Hamburg
Country
Germany
Facility Name
UKE Hamburg
City
Hamburg
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Heart Center of the University of Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum der Universität Munchen
City
Munich
Country
Germany
Facility Name
University of Milano
City
Milano
Country
Italy
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Hyōgo
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo
Country
Japan
Facility Name
Tottori University Hospital
City
Tottori
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
Country
Japan
Facility Name
VU University Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Facility Name
Maastricht UMC Hart & Vaat Centrum
City
Maastricht
Country
Netherlands
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Fourth Military Hospital
City
Wroclaw
Country
Poland
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Facility Name
Golden Jubilee Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Guys & St Thomas NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35120593
Citation
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.
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REDUCE LAP-HF TRIAL II

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