| CTRI Number |
CTRI/2011/091/000195 [Registered on: 15/02/2011] |
| Last Modified On: |
12/10/2018 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE BACE DEVICE IN THE TREATMENT OF FUNCTIONAL MITRAL REGURGITATION |
Scientific Title of Study
Modification(s)
|
Evaluation of acute safety and efficacy of the BACE [Basal Annuloplasty of the Cardia Externally] device in the treatment of Function Mitral valve Regurgitation [FMR]
|
| Trial Acronym |
BACE CT001; MA-CT-08-004 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BACE CT001; MA-CT-08-004 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jai Shankar Raman, Cardiothoracic Surgeon |
| Designation |
|
| Affiliation |
|
| Address |
8-2-546, Sheesh Mahal, Nr. Meridian School
Road No: 7, Banjara Hills
Hyderabad
ANDHRA PRADESH
500 034
India |
| Phone |
+91-40-23551046 |
| Fax |
+91-40-23351047 |
| Email |
jairaman24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Mittal |
| Designation |
|
| Affiliation |
Director - Research and Clincial Cardiology |
| Address |
Medanta - The Medicity,Sector -38,
Near Tau Devi Lal Stadium
Not Applicable
N/A
India |
| Phone |
09910044477 : 09971698159 |
| Fax |
0124 - 4834111 |
| Email |
sanjay.mittal@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shariq Anwar |
| Designation |
|
| Affiliation |
|
| Address |
Max Neeman International Limited,Max House, 1 Dr Jha Marg,
Okhla Phase 3
New Delhi
DELHI
110021
India |
| Phone |
+91.11.2632 4059, 2632 2824 |
| Fax |
+91.11.2632 2846 |
| Email |
sanwar@neemanasia.com |
|
|
Source of Monetary or Material Support
|
| Mardil Medical Device Pvt. Ltd.
20B,ASCI College Park,
Road#3,Banjara Hills,
Hyderabad 500034, India
Ph:+91-40-23550481
|
|
|
Primary Sponsor
|
| Name |
Mardil Medical Device Pvt. Ltd.
20B,ASCI College Park,
Road#3,Banjara Hills,
Hyderabad 500034, India
Ph:+91-40-23550481
Fax:+91-40-23550487 |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal Acunova Limited, Mobius Towers, SJR i Park EPIP, Whitefield,
Bangalore - 560 066, India |
|
| Max Neeman International Limited.
Max House, 1 Dr Jha Marg,
Okhla Phase 3
New Delhi 110021
Phone: +91.11.2632 4059, 2632 2824
Fax: +91.11.2632 2846
Website: www.neeman-medical.com
|
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Srinivasa Kumar |
Care Hospital |
Road No. 1, Banjara Hills,-500034
Hyderabad
ANDHRA PRADESH |
40 30418126
040 66831878
arramraj@yahoo.com |
| Dr P. Chandrasekhar, Consultant Cardiothoracic and Vascular Surgery, |
GKNM Hospital |
,-
Coimbatore
TAMIL NADU |
0422 4214109
0422 4214109
chanpad@gmail.com |
| Dr Naresh Trehan |
Medanta Heart Institute, The Medicity |
,-122 001
Gurgaon
HARYANA |
+91- 124 4141414
+91- 124 4834 111
naresh.trehan@medanta.org |
| Dr R. Jaganathan |
Railway Hospital |
,-
Chennai
TAMIL NADU |
044 26743031
044 26743051
yezzjag@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| . CLINICOM,Bangalore , Karnataka, India |
Approved |
| . Institutional Ethics Committee, |
Approved |
| Institutional Review Board |
Approved |
| Medanta Independent Ethics Committee, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
FUNCTIONAL MITRAL VALVE REGURGITATION OF GRADE MODERATE TO SEVERE WHERE SURGERY IS THE DESIRED OPTION OF TREATMENT AS PER THE INVESTIGATOR, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACE Device |
BACE Device |
| Comparator Agent |
Not Applicable |
|
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
? Adults from 18 to 80 years of age, inclusive; either gender
? Symptomatic functional MR of grade moderate to severe (2 to 4 as per the ACC and AHA 2006 Classification of Mitral regurgitation evaluation NYHA Class II to IV
? LVEF 25%-50%
? Normal mitral valve leaflets
? Subject is willing and available to return for study follow up
? Surgical approach is the treatment option
? Ability of the subject or legal representative to understand and provide signed consent for participating in the study
|
|
| ExclusionCriteria |
| Details |
? Subjects will be excluded if they meet any of the following criteria
? Known hypersensitivity or allergy to the device materials
? History or presence of rheumatic heart disease
? Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets)
? Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg
? Severe diastolic dysfunction of left ventricle on ECHO [restrictive filling pattern, characterized by E>> A, decreased IVRT, and decreased DT as seen with restrictive cardiomyopathies with LV ejection fractions of > 40%)
? 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 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
? Creatinine > 2.5 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint: Reduction in MR grade to 1+ or less after the implantation of the BACE device and through the 6 month feasibility phase as measured by echocardiography |
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Durability of or improvement in MR grade over the additional 18-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] over the initial 6 month feasibility and the additional 18-month follow-up periods.
|
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/02/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open label, multi centre trial to evaluate the safety and efficacy of the BACE device in the patients of Functional Mitral Regurgitation whom surgery is preferred treatment as per the Investigator. The primary efficacy endpoint will be reduction of MR to 1+ or less from the baseline MR grade through the 6 month feasibility phase. Primary safety endpoint will be freedom from major devise and surgery-related adverse events for the duration of 6 months. Total 20 patients will be enrolled in India. |