A clinical trial to evaluate the immediate safety and efficacy of BACE Device in the treatment of functional mitral valve regurgitation.

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2009/091/000577
• Date of registration: 17-08-2009
• Primary sponsor: Mardil Medical Medical Devices Pvt Ltd. 20B, ASCI College Park, Road #3, Banjara Hills, Hyderabad 500034, India
• Public title: A clinical trial to evaluate the immediate safety and efficacy of BACE Device in the treatment of functional mitral valve regurgitation.
• Scientific title: Evaluation of acute safety and efficacy of the BACE [Basal Annuloplasty of the Cardia Externally] device in the treatment of Functional Mitral valve Regurgitation [FMR].
• Date of first enrolment: 04-12-2008
• Target sample size: 20
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=776
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable

Countries of recruitment

India

Contacts

• Name: Dr. Krishna Talluri

• Name: Dr. Krishna Talluri

Key inclusion & exclusion criteria

Inclusion criteria: - Adults from 18 to 80 years of age, inclusive; either gender
- MR of grades 2 and above [Grade 2 or more functional mitral valve regurgitation per 2D or 3D transthoracic echocardiography, must be symptomatic which is defined as NYHA Class ≥ II or heart failure subject with MR
- Functional MR with coronary artery disease or aortic valve disease
- Subject undergoing concomitant coronary artery bypass graft or aortic valve surgery
- Appropriate valve anatomy [normal mitral valve leaflets]
- Subject is willing and available to return for study follow up
- Ability of the subject or legal representative to understand and provide signed consent for participating in the study

Exclusion criteria: - Known hypersensitivity or allergy to the device materials
- Known hypersensitivity or allergy to the device materials
- NYHA Class IV after optimal medical therapy
- Structural abnormality of the mitral valve
- High pulmonary arterial pressure
- Severe diastolic dysfunction of left ventricle on ECHO
- Transmural myocardial infarction [MI] with in 30 days of enrollment in the study; non ST segment elevation MI within 7days of enrollment in the study
- Currently enrolled in another investigational drug or device protocol that would interfere with this study
- Subjects with heart size outside of offered BACE device size ranges [25 to 41 cm; correlate to pre-op measurement end diastolic dimension]
- Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE
- Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures
- Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement
- Prior Coronary Artery Bypass Graft (CABG) surgery
- Acute active infection
- Active peptic ulcer
- History of IV drug abuse
- Chronic renal failure requiring dialysis
- Ejection fraction < 25%
- Creatinine > 3.0 mg/dl
- Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis]
- Immune suppression therapy
- Subjects with chronic connective tissue disease
- Investigator judgment that body habitus or sternal anatomy precludes pericardial access
- Females who are pregnant or lactating
- Life expectancy of less than 12 months due to conditions other than cardiac status

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Functional Mitral Regurgitation

Intervention(s)

Intervention1: BACE Device: Implantation
Control Intervention1: Nil: Nil

Primary Outcome(s)

All device and surgery-related averse events and other adverse events over the course of the studyTimepoint: At baseline, post implantaion, at hospital discharge,1, 3, 6, and 12 month post implantaion

Primary Outcome:
Reduction of MR by at least one grade after the implantation of the BACE device as measured by ECHO cardiographic parametersTimepoint: at baseline, peri surgery (just before and right after BACE device implantation), at hospital discharge, 1, 3, 6, and 12 months post device implantation

Secondary Outcome(s)

Durability of or improvement in MR grade over the 12-month follow-up period as measured by echocardiography Improvement in cardiac functionality [as assessed by the NYHA functional class, and Minnesota Living with Heart Failure questionnaire (MLHFQ) over the 12-month follow-up periods. NYHA status, and MLHFQ evaluations at baseline, discharge from hospital,1, 3, 6, and 12 months post BACE Device implantation.





Timepoint: at baseline, peri surgery (just before and right after BACE device implantation), at hospital discharge, 1, 3, 6, and 12 months post device implantation

Secondary ID(s)

Study Number: BACE CT001, ; MA-CT-08-004

Source(s) of Monetary Support

Mardil Medical Medical Devices Pvt Ltd. Hyderabad 500034

Secondary Sponsor(s)

CRO: Manipal Acunova Limited Mobius Towers, SJR i Park EPIP, Whitefield Bangalore - 560 066 India Ph : 08066915700 Fax : [phone]