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Randomized Evaluation and Verification of Ventricular Enhancement (REVIVE-HF)

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ClinicalTrials.gov Identifier: NCT03845127
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Imaging Clinical Trial Services GmbH, Meditrial Europe Ltd.
Information provided by (Responsible Party):
BioVentrix

Brief Summary:
A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Heart Failure Device: Revivent TC Ventricular Enhancement System Drug: GDMT Not Applicable

Detailed Description:
The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2:1 Randomized Study Design. Crossover permitted after 6 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Revivent TC Ventricular Enhancement System plus GDMT
Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Device: Revivent TC Ventricular Enhancement System
Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.

Drug: GDMT
Guideline Directed Medical Therapy

Active Comparator: GDMT Only
Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Drug: GDMT
Guideline Directed Medical Therapy




Primary Outcome Measures :
  1. 6 Minute Walking Distance [ Time Frame: 3 and 6 months after enrollment ]
    Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.


Secondary Outcome Measures :
  1. Quality of Life Index [ Time Frame: 3 and 6 months after enrollment ]
    Changes in Quality of Life Index measured compared to baseline using the MLHFQ Quality of Life Questionnaire.

  2. NYHA Classification [ Time Frame: 3 and 6 months after enrollment ]
    Changes in NYHA Heart Classification compared to baseline

  3. LVESVI and LVEDVI [ Time Frame: 3 and 6 months after enrollment ]
    Changes in left ventricular end systolic volume index (LVESVI) end diastolic volume index (LVEDVI) measured by echocardiogram compared to baseline

  4. LVEF [ Time Frame: 3 and 6 months after enrollment ]
    Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.

Exclusion Criteria:

  • Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
  • Inadequate myocardial viability in regions remote from the scar.
  • Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
  • Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
  • Patient intolerance or unwillingness to take anti-coagulation medication;
  • Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
  • Pulmonary Arterial Pressure > 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
  • Myocardial Infarction within 90 days prior to the procedure;
  • Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
  • Chronic renal failure with a serum creatinine >2 mg/dL;
  • Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
  • Baseline 6-minute walk distance of >450m

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): NCT03845127


Contacts
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Contact: Noel Messenger, MBA +1925-830-1000 ext 231 nmessenger@bioventrix.com
Contact: Nick Corso +1925-830-1000 ext 207 ncorso@bioventrix.com

Sponsors and Collaborators
BioVentrix
Imaging Clinical Trial Services GmbH, Meditrial Europe Ltd.
Investigators
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Principal Investigator: Stefan Anker, MD Berlin-Brandenburger Centrum für Regenerative Therapien (BCRT) und Medizinische Klinik m. S. Kardiologie
Principal Investigator: Volkmar Falk, MD Ärztlicher Direktor, Direktor der Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin

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Responsible Party: BioVentrix
ClinicalTrials.gov Identifier: NCT03845127     History of Changes
Other Study ID Numbers: CIP-0080
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by BioVentrix:
Ischemic Cardiomyopathy, Heart Failure, Revivent TC System
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases