REDUCE LAP-HF TRIAL

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913613
• Other study ID #: 2013-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 2018

Study information

• Verified date: July 2020
• Source: Corvia Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Key Inclusion Criteria:

1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

1. 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;

2. 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);

3. 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).

2. Age = 40 years old

3. Left ventricular ejection fraction (obtained by echocardiography) = 40%

4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :

1. PCWP or LVEDP at rest = 15 mmHg, and greater than CVP, OR

2. PCWP during supine bike exercise = 25mm Hg, and CVP < 20 mm Hg

Key Exclusion Criteria:

3. Severe heart failure defined as:

1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;

2. Fick Cardiac Index < 2.0 L/min/m2

3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months

4. 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• IASD
IASD device implantation

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane
Australia	David Kaye	Melbourne
Australia	St. Vincent Hospital	Sydney
Austria	Medizinische Universität Graz	Graz
Austria	Allgemeines Krankenhaus Univesitäts Kliniken	Vienna
Belgium	OLVZ Aalst	Aalst
Czechia	Homolka Hospital	Prague
Denmark	Rigshospitalet	Copenhagen
France	CHRU de Lille	Lille
France	CHU de Nantes	Nantes
France	Hôpital Bichat	Paris
France	Hôpital La Pitié Salpétrière	Paris
France	Hôpital Rangueil	Toulouse
Germany	Universitatklinikum Duseldorf	Dusseldorf
Germany	Georg-August-Universitat	Gottingen
Germany	Asklepios Klinik St George	Hamburg
Germany	Cardiologicum CRC	Hamburg
Germany	University of Heidelberg	Heidelberg
Germany	Universtitaät Kliniku Schlewig Holstein	Kiel
Germany	Klinikum der Universität Munchen	Munich
Netherlands	St Antonius Ziekenhuis	Nieuwegein
New Zealand	Auckland City Hospital	Auckland
Poland	Fourth Military Hospital	Wroclaw
United Kingdom	Golden Jubilee Hospital	Glasgow
United Kingdom	Royal Brompton/Harefield Trust	Harefield
United Kingdom	King's College	London

Sponsors (1)

Lead Sponsor	Collaborator
Corvia Medical

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  Netherlands,  New Zealand,  Poland,  United Kingdom, 

References & Publications (7)

Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfuß 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 — View Citation

Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hünlich 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. — View 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 prese — View 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, — View Citation

Kaye DM, Petrie MC, McKenzie S, Hasenfuß 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 — View Citation

Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfuß 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 — View 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 H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months