Randomized Evaluation and Verification of Ventricular Enhancement (REVIVE-HF)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03845127|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Cardiomyopathy Heart Failure||Device: Revivent TC Ventricular Enhancement System Drug: GDMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2:1 Randomized Study Design. Crossover permitted after 6 months.|
|Masking:||None (Open Label)|
|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|
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.
Guideline Directed Medical Therapy
Active Comparator: GDMT Only
Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
Guideline Directed Medical Therapy
- 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.
- 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.
- NYHA Classification [ Time Frame: 3 and 6 months after enrollment ]Changes in NYHA Heart Classification compared to baseline
- 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
- LVEF [ Time Frame: 3 and 6 months after enrollment ]Changes in left ventricular ejection fraction (LVEF) measured by echocardiogram compared to baseline
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
|Contact: Noel Messenger, MBA||+1925-830-1000 ext firstname.lastname@example.org|
|Contact: Nick Corso||+1925-830-1000 ext email@example.com|
|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|