Observational study to collect data on health improvements after mini-invasive operation with Revivent TC device to reshape the heart and reduce its volume

• Register: ISRCTN
• Last refreshed on: 19 December 2016
• Main ID: ISRCTN89757315
• Date of registration: 29/11/2016
• Prospective Registration: No
• Primary sponsor: BioVentrix, Inc.
• Public title: Observational study to collect data on health improvements after mini-invasive operation with Revivent TC device to reshape the heart and reduce its volume
• Scientific title: BRAVE-TC: BioVentrix registry assessment of ventricular enhancement for the Revivent TC™ system
• Date of first enrolment: 19/10/2016
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN89757315
• Study type: Observational
• Study design: Multi-center prospective single-arm post-market registry (Treatment)

Countries of recruitment

Czech Republic, Germany, Italy, Switzerland

Contacts

• Name: Noel Messenger

• Name: Monica Tocchi

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased ventricular volume and anteroseptal or apical scar

Additional general inclusion criteria:
2. Subject is >18 years of age
3. Subject is able and willing to provide written informed consent
4. Subject is on guideline directed medical therapy (GDMT) for heart failure
Exclusion criteria: 1. Inadequate myocardial viability in regions remote from the scar
2. Thrombus or intra-ventricular mass
3. Cardiac Resynchronization Therapy (CRT)
4. Patient intolerance or unwillingness to take anti-coagulation medication
5. Functioning pacemaker leads in antero-apical RV
6. Pulmonary Arterial Pressure > 60 mm Hg
7. Myocardial Infarction less than 90 days before the procedure
8. Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement
9. Chronic renal failure with a serum creatinine >2 mg/dL
10. Inoperable coronary disease with significant ischemia
11. Pulmonary disease that would preclude transient single lung ventilation

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Heart failure due to ischemic cardiomyopathy
Circulatory System
Ischaemic cardiomyopathy

Intervention(s)

Participants receive ventricular reduction as part of their standard care. Prior to the operation, Cardiac Magnetic Resonance or Cardiac Tomography shall be used (according to institutional practice) to determine the extent of the area to treat and to qualify the patients for therapy. Ultra-sound examination (Transthoracic echocardiogram) shall be used to assess the size and shape of the heart before and after treatment. A 6-minute walking test shall be used to assess clinical status.
All adverse events are recorded prior to hospital discharge and at 30-days after treatment.
At 6 months, 1 year and annually for 5 years participants undergo the following assessments:
1. Physical examination
2. EKG
3. Cardiac imaging by Transthoracic Echocardiography according to institutional practice
4. Heart Failure Status (NYHA functional classification)
5. Quality of Life Assessment (Minnesota Living with Heart Failure Questionnaire, EuroQol-5D questionnaire)
6. 6-Minute Walk Test according to institutional practice
7. Data regarding any emergent treatment(s), heart failure related rehospitalization and/or adverse events

Primary Outcome(s)

Decrease in Left Ventricular volume is measured using echocardiography at 6 months, 1, 2, 3, 4 and 5 years.

Secondary Outcome(s)

Changes in heart failure status assessed by Left Ventricular Ejection Fraction, New York Heart Association class, quality of life assessment, and walking distance as measured by a 6-minute walk exam at baseline, 6 months, 1, 2, 3, 4 and 5 years.

Secondary ID(s)

CIP-0073

Source(s) of Monetary Support

BioVentrix, Inc.