| CTRI Number |
CTRI/2012/10/003045 [Registered on: 08/10/2012] Trial Registered Prospectively |
| Last Modified On: |
18/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to assess the safety and efficacy of the BACE device for
the treatment of functional mitral valve regurgitation
|
|
Scientific Title of Study
|
Evaluation of Safety and Efficacy of the BACEâ„¢ [Basal Annuloplasty of the Cardia
Externally] Device in the Treatment of Functional Mitral Valve Regurgitation [FMR]
|
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BACE CT003, Version-1.2 dated 18 Nov 2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr P Chandrasekar |
| Designation |
Cardiothoracic Surgeon |
| Affiliation |
G Kuppuswamy Naidu Memorial Hospital |
| Address |
Department of Cardiothoracic Surgery, A-Block-2nd floor, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam
Coimbatore
TAMIL NADU
641037
India |
| Phone |
91-422-3293097 |
| Fax |
91-422-4214109 |
| Email |
chanpad@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Diptendu Santra |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-8698065660 |
| Fax |
91-01296613520 |
| Email |
diptendu.santra@jssresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Gopal Muppirala |
| Designation |
Chief Executive Officer |
| Affiliation |
Phoenix Cardiac Devices Pvt. Ltd. |
| Address |
# 1-7-23/26
JSN Colony, Street No: 8
Habsiguda
Hyderabad
ANDHRA PRADESH
500007
India |
| Phone |
91-9676182504 |
| Fax |
|
| Email |
gopal@phoenixcardiac.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Phoenix Cardiac Devices, Pvt. Ltd.
# 1-7-23/26
JSN Colony, Street No: 8
Habsiguda, Hyderabad - 500007, India |
|
Primary Sponsor
Modification(s)
|
| Name |
Phoenix Cardiac Devices Pvt Ltd |
| Address |
# 1-7-23/26
JSN Colony, Street No: 8
Habsiguda, Hyderabad - 500007, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| JSS Medical Research India Private Limited |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad, Haryana-121003,
India
|
|
Countries of Recruitment
Modification(s)
|
India
Czech Republic
United Kingdom
Canada
Poland |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Chandrasekar Padmanabhan |
GKNM Hospital |
Cardiothoracic surgeon,
Department of cardiothoracic surgery,
A block-2nd floor,
G Kuppusamy Naidu Memorial hospital,
Post box no:6327,Pappanaicken palayam,
Coimbatore-641037
Coimbatore
TAMIL NADU |
91-422-3293097
91-422-4214109
chanpad@gmail.com |
| Dr Shiv Kumar Choudhary |
All India Institute of Medical Sciences |
AIIMS Hospital, Ansari Nagar-110029
New Delhi
DELHI |
91-11-26589388
shivchoudhary@hotmail.com |
| Dr Alla Gopala Krishna Gokhale |
Apollo Hospital |
Jubilee Hills
Hyderabad
TELANGANA |
9848045810
drokhale@drgokhale.com |
| Dr Bikash Rai Das |
GNRC Hospital |
Supermarket Dispur,
Guwahati - 781006, India
Kamrup
ASSAM |
91-9859273504
drbrdas@gmail.com |
| Dr Richard Saldanha |
KLE Hospital |
KLE University, JN Medical College, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA |
7090369888
rsaldanha5662@gmail.com |
| Dr Anil Kumar Agrawal |
Maharaja Agrasena Hospital |
West Punjabi Bagh
New Delhi
DELHI |
9910996627
annutaru@yahoo.com |
| Dr Vishal Agarwal |
Paras Hospital |
C-1, Sushant Lok- 1, Sector - 43
Gurgaon
HARYANA |
91-9927030110
drvishal001@rediffmail.com |
| Dr Manoj Durairaj |
Ruby Hall Clinic |
Director Cardiac surgery, Dept. of Cardiology,Ruby Hall Clinic,40,Sassoon Road-411001
Pune
MAHARASHTRA |
91-9822322072
91-020-26346867
manojdurairaj@hotmail.com |
| Dr Anil R Jain |
SAL Hospital |
Clinical Research Department
Room Number 812, 8th Floor,
SAL Hospital, Opp. Doordarshan Tower.
Drive- In-Road, Thaltej
Ahmedabad 380 054,
Gujarat , India
Ahmadabad
GUJARAT |
91-79-66115600
91-79-66115620
dranilrjain@yahoo.co.in |
| Dr PS Seetharama Bhat |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
Bannerghatta main road- 560069
Bangalore
KARNATAKA |
919448046534
pssbhat@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| AIIMS-Institutional Ethics Committee |
Approved |
| Ethics Committee, Institute of Neurological Sciences, GNRC Hospital |
Approved |
| Institutional Ethics Committee Apollo Hospital,Hyderabad |
Approved |
| Institutional Ethics Committee KLE Hospital |
Approved |
| Institutional Ethics Committee Paras Hospital |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee, Ruby Hall |
Approved |
| Institutional review board SAL Hospital and Medical Institute |
Approved |
| Sri Jayadeva Institute Ethics Committee |
Approved |
| The Ethics Committee, GKNM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Functional Mitral Valve Regurgitation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACE device |
The BACE device is based on a new technique that provides support and remodels the base of the heart externally. By doing so it brings the mitral valve leaflets closer for proper closure of the valve eliminating the MR. The device consists of a wide, clear dimethylsilicone bandassembly with inflatable silicone chambers and small belt loops of polyester around the band.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults from 18 to 80 years of age, inclusive; either gender
2) Functional MR of moderate to severe grade (2 to 4 as per the ACC and AHA 2006 Classification of Mitral regurgitation evaluation)
3) Symptomatic- NYHA Class II to IV
4) LVEF 25%-50%
5) Normal mitral valve leaflets without any abnormalities and damage
6) Subject is willing and available to return for study follow-up
7) Surgical approach is the treatment option
8) Ability of the subject or legal representative to understand and provide signed consent for participating in the study |
|
| ExclusionCriteria |
| Details |
1) Known hypersensitivity or allergy to the device materials
2) History or presence of rheumatic heart disease
3) Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets)
4) Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg
5) Grade 4 diastolic dysfunction of left ventricle on ECHO, with no change by hemodynamic maneuvers
6) ST segment elevation myocardial infarction [MI] within 30 days of enrollment in the study; non ST segment elevation MI within 7days of enrollment in the study
7) Currently enrolled in another investigational drug or device study
8) Subjects with intra operative [correlate to pre-op measurement end diastolic dimension] heart circumference outside of offered BACE device size ranges [25 to 41 cm]
9) Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE
10) Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures
11) Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement
12) Prior Coronary Artery Bypass Graft (CABG) surgery
13) Acute active infection
14) Active peptic ulcer
15) History of IV drug abuse
16) Chronic renal failure requiring dialysis
17) Creatinine 2.5 mg/dL
18) Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis,
myocarditis, pericarditis]
19) Immune suppression therapy including corticosteroids
20) Subjects with chronic connective tissue disease •Investigator judgment that body habitus or sternal anatomy precludes pericardial access
21) Females who are pregnant or lactating
22) 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
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The primary efficacy end point will be reduction of MR to 1 plus or less from the baseline MR Grade through the 24-month study period.
Primary safety endpoint will be freedom from major device and surgery related adverse events (listed in the adverse events section) for the duration of the 24 month follow up period. |
24 Months follow up period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
08/10/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None as Yet |
|
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
study periods.
Primary safety endpoint will be freedom
from major devise and surgery-related adverse
events for the duration of 6 months.
|