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REDUCE LAP-HF RANDOMIZED TRIAL I

Sponsor
Corvia Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02600234
Collaborator
(none)
44
Enrollment
21
Locations
2
Arms
128
Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Inter-Atrial Shunt Device
  • Other: Intracardiac Echo
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Dec 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) [1 Month Post Implant]

      The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as: Cardiovascular death through 1-month post implant; Embolic stroke through 1-months post implant; Device and or procedure related adverse cardiac events through 1-month post implant; New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 1-month post implant

    2. Change in supine exercise pulmonary capillary wedge pressure (PCWP) [1 Month Post Implant]

      Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).

    Secondary Outcome Measures

    1. Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline [1 Month]

    2. Cardiovascular death [12 Months]

    3. Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF [12 Months]

    4. Change in Quality Of Life Questionnaire (EQ-5D) [12 Months]

    5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) [12 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona College of Medicine Tucson Arizona United States 85724
    2 Yale University New Haven Connecticut United States 06510
    3 Northwestern University Chicago Illinois United States 60611
    4 Evanston Northshore Healthcare Evanston Illinois United States 60201
    5 Cardiovascular Institute of the South Houma Louisiana United States
    6 Ochsner Medical Center New Orleans Louisiana United States 70121
    7 Massachusetts General Hospital Boston Massachusetts United States
    8 University of Michigan Health System Ann Arbor Michigan United States 41809
    9 Mayo Clinic Rochester Minnesota United States 55905
    10 Columbia University Medical Center/NewYork Presbyterian Hospital New York New York United States
    11 Mt. Sinai Hospital New York New York United States
    12 New York University New York New York United States
    13 Wake Forest Winston-Salem North Carolina United States
    14 Ohio Health Columbus Ohio United States
    15 Ohio State University College of Medicine Columbus Ohio United States
    16 University of Pennsylvania Philadelphia Pennsylvania United States
    17 Medical University of South Carolina Charleston South Carolina United States
    18 The Alfred Hospital Melbourne Australia
    19 OLVZ Aalst Aalst Belgium
    20 UMC Groningen Groningen Netherlands
    21 Golden Jubilee Hospital Glasgow United Kingdom

    Sponsors and Collaborators

    • Corvia Medical

    Investigators

    • Principal Investigator: Sanjiv Shah, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Corvia Medical
    ClinicalTrials.gov Identifier:
    NCT02600234
    Other Study ID Numbers:
    • 1501
    First Posted:
    Nov 9, 2015
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 22, 2022