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REDUCE LAP-HF TRIAL (REDUCE LAP-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913613
First Posted: August 1, 2013
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corvia Medical
  Purpose
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.

Condition Intervention
Heart Failure Device: IASD

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Corvia Medical:

Primary Outcome Measures:
  • MACCE [ Time Frame: 6 months ]
    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)


Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment with the IASD device
Device: IASD
IASD device implantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913613


Locations
Australia
The Prince Charles Hospital
Brisbane, Australia
David Kaye
Melbourne, Australia
St. Vincent Hospital
Sydney, Australia
Austria
Medizinische Universität Graz
Graz, Austria
Allgemeines Krankenhaus Univesitäts Kliniken
Vienna, Austria
Belgium
OLVZ Aalst
Aalst, Belgium
Czechia
Homolka Hospital
Prague, Czechia
Denmark
Rigshospitalet
Copenhagen, Denmark
France
CHRU de Lille
Lille, France
CHU de Nantes
Nantes, France
Hôpital Bichat
Paris, France
Hôpital La Pitié Salpétrière
Paris, France
Hôpital Rangueil
Toulouse, France
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, Germany
Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
New Zealand
Auckland City Hospital
Auckland, New Zealand
Poland
Fourth Military Hospital
Wroclaw, Poland
United Kingdom
Golden Jubilee Hospital
Glasgow, United Kingdom
Royal Brompton/Harefield Trust
Harefield, United Kingdom
King's College
London, United Kingdom
Sponsors and Collaborators
Corvia Medical
Investigators
Study Chair: Jan Komtebedde, DVM Corvia Medical