Back to resultsREDUCE LAP-HF TRIAL (REDUCE LAP-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IASD
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Key Inclusion Criteria:
Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
- One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
- On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
- Age ≥ 40 years old
- Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
- PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg
Key Exclusion Criteria:
3. Severe heart failure defined as:
- ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- Fick Cardiac Index < 2.0 L/min/m2
- Requiring inotropic infusion (continuous or intermittent) within the past 6 months
- Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
Sites / Locations
- The Prince Charles Hospital
- David Kaye
- St. Vincent Hospital
- Medizinische Universität Graz
- Allgemeines Krankenhaus Univesitäts Kliniken
- OLVZ Aalst
- Homolka Hospital
- Rigshospitalet
- CHRU de Lille
- CHU de Nantes
- Hôpital Bichat
- Hôpital La Pitié Salpétrière
- Hôpital Rangueil
- Universitatklinikum Duseldorf
- Georg-August-Universitat
- Asklepios Klinik St George
- Cardiologicum CRC
- University of Heidelberg
- Universtitaät Kliniku Schlewig Holstein
- Klinikum der Universität Munchen
- St Antonius Ziekenhuis
- Auckland City Hospital
- Fourth Military Hospital
- Golden Jubilee Hospital
- Royal Brompton/Harefield Trust
- King's College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment with the IASD device
Outcomes
Primary Outcome Measures
MACCE
subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01913613
Brief Title
REDUCE LAP-HF TRIAL
Acronym
REDUCE LAP-HF
Official Title
REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvia Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with the IASD device
Intervention Type
Device
Intervention Name(s)
IASD
Intervention Description
IASD device implantation
Primary Outcome Measure Information:
Title
MACCE
Description
subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
Age ≥ 40 years old
Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg
Key Exclusion Criteria:
3. Severe heart failure defined as:
ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
Fick Cardiac Index < 2.0 L/min/m2
Requiring inotropic infusion (continuous or intermittent) within the past 6 months
Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Komtebedde, DVM
Organizational Affiliation
Corvia Medical
Official's Role
Study Chair
Facility Information:
Facility Name
The Prince Charles Hospital
City
Brisbane
Country
Australia
Facility Name
David Kaye
City
Melbourne
Country
Australia
Facility Name
St. Vincent Hospital
City
Sydney
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
Allgemeines Krankenhaus Univesitäts Kliniken
City
Vienna
Country
Austria
Facility Name
OLVZ Aalst
City
Aalst
Country
Belgium
Facility Name
Homolka Hospital
City
Prague
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
CHRU de Lille
City
Lille
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
Hôpital Rangueil
City
Toulouse
Country
France
Facility Name
Universitatklinikum Duseldorf
City
Dusseldorf
Country
Germany
Facility Name
Georg-August-Universitat
City
Gottingen
Country
Germany
Facility Name
Asklepios Klinik St George
City
Hamburg
Country
Germany
Facility Name
Cardiologicum CRC
City
Hamburg
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universtitaät Kliniku Schlewig Holstein
City
Kiel
Country
Germany
Facility Name
Klinikum der Universität Munchen
City
Munich
Country
Germany
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Fourth Military Hospital
City
Wroclaw
Country
Poland
Facility Name
Golden Jubilee Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Royal Brompton/Harefield Trust
City
Harefield
Country
United Kingdom
Facility Name
King's College
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26055211
Citation
Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.
Results Reference
background
PubMed Identifier
27025436
Citation
Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.
Results Reference
result
PubMed Identifier
27852653
Citation
Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.
Results Reference
result
PubMed Identifier
28949052
Citation
Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.
Results Reference
result
PubMed Identifier
30311437
Citation
Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.
Results Reference
result
PubMed Identifier
30354556
Citation
Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.
Results Reference
result
PubMed Identifier
31653352
Citation
Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.
Results Reference
result
PubMed Identifier
31753198
Citation
Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.
Results Reference
derived
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REDUCE LAP-HF TRIAL
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