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REDUCE LAP-HF RANDOMIZED TRIAL I

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.
 
ClinicalTrials.gov Identifier: NCT02600234
Recruitment Status : Active, not recruiting
First Posted : November 9, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Brief Summary:
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Inter-Atrial Shunt Device Other: Intracardiac Echo Not Applicable

Detailed Description:
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment with Inter-Atrial Shunt Device
Once all study criteria have been met, if randomized to this arm, patients will receive the IASD implant.
Device: Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum
Other Name: IASD

Placebo Comparator: Control
Once all study criteria have been met, if randomized to this arm, patients will not receive the implant. They will undergo an intracardiac echo only, with the option to crossover at 1 year.
Other: Intracardiac Echo
Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.




Primary Outcome Measures :
  1. The change in supine exercise PCWP from baseline [ Time Frame: 1 Month Post Procedure ]
  2. The composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) [ Time Frame: 1 Month Post Procedure ]


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

Key Inclusion Criteria:

  • Chronic symptomatic Heart Failure
  • Ongoing stable GDMT HF management and management of potential comorbidities
  • Age ≥ 40 years old
  • LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
  • Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

  • MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
  • Cardiac Resynchronization Therapy initiated within the past 6 months
  • Severe heart failure
  • 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
  • Known clinically significant untreated carotid artery stenosis
  • Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

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): NCT02600234


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 41809
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mt. Sinai Hospital
New York, New York, United States
United States, North Carolina
Wake Forest
Winston-Salem, North Carolina, United States
United States, Ohio
Ohio Health
Columbus, Ohio, United States
Ohio State University College of Medicine
Columbus, Ohio, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
Australia
The Alfred Hospital
Melbourne, Australia
Belgium
OLVZ Aalst
Aalst, Belgium
Netherlands
UMC Groningen
Groningen, Netherlands
United Kingdom
Golden Jubilee Hospital
Glasgow, United Kingdom
Sponsors and Collaborators
Corvia Medical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT02600234     History of Changes
Other Study ID Numbers: 1501
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases