REDUCE LAP-HF TRIAL (REDUCE LAP-HF)

July 13, 2020 updated by: Corvia Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment with the IASD device
Device: IASD
IASD device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvia Medical

Investigators

  • Study Chair: Jan Komtebedde, DVM, Corvia Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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