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CTRI Number  CTRI/2011/04/001658 [Registered on: 01/04/2011] Trial Registered Retrospectively
Last Modified On: 21/11/2011
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment. 
Scientific Title of Study   Clinical Outcome of Pacemaker paTIents according to pacing Modality and primary INDications  
Trial Acronym  OPTI-MIND 
Secondary IDs if Any  
Secondary ID  Identifier 
CIP Ref. No.: 07-09  Protocol Number 
NCT00976482  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bina Naik 
Designation  Medical and Managing Director 
Affiliation  Vibgyor Scientific Research Pvt Ltd 
Address  Overall Trial Coordinator, Medical and Managing Director, Vibgyor Scientific Research Pvt Ltd. 45, World Business House, Near Parimal Garden, Ellisbridge

Ahmadabad
GUJARAT
380006
India 
Phone  917926565076  
Fax  917926563942  
Email  bina.naik@vibgyorcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bina Naik 
Designation  Medical and Managing Director 
Affiliation  Vibgyor Scientific Research Pvt Ltd 
Address  Overall Trial Coordinator, Medical and Managing Director, Vibgyor Scientific Research Pvt Ltd. 45, World Business House, Near Parimal Garden, Ellisbridge

Ahmadabad
GUJARAT
380006
India 
Phone  917926565076  
Fax  917926563942  
Email  bina.naik@vibgyorcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Bina Naik 
Designation  Managing and Medical Director 
Affiliation  Vibgyor Scientific Research Pvt Ltd. 
Address  Medical and Managing Director, Vibgyor Scientific Research Pvt Ltd. 45, World Business House, Nr Parimal Garden, Ellisbridge, Ahmedabad

Ahmadabad
GUJARAT
380006
India 
Phone  917926565076  
Fax  917926563942  
Email  bina.naik@vibgyorcare.com  
 
Source of Monetary or Material Support  
Guidant Europe/a Boston Scientific Company, International CRM/EP Clinical Research Department, Green Square, Lambroekstraat 5D, 1831 Diegem, Belgium 
 
Primary Sponsor  
Name  Guidant Europe a Boston Scientific Company Europe 
Address  International CRM Clinical Research Department Green Square, Lambroekstraat 5D, 1831 Diegem, Belgium  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     Austria
Canada
Czech Republic
Denmark
France
Germany
Greece
India
Italy
Netherlands
Portugal
Slovakia
Spain
Switzerland
United Kingdom  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjinder Singh Sandhu  Artemis Health Institute  Sector 51, Gurgaon, Haryana - 122001 INDIA
Gurgaon
HARYANA 		 911246767999
911246767701
manjinder@artemishealthsciences.com 
Dr Ajay Naik  Care Institute of Medical Sciences  Off. Science City Road, Nr Sukan Mall, Sola, Ahmedabad - 380063, INDIA
Ahmadabad
GUJARAT 		 917927712770
917927712777
ajay.naik@cims.me 
Dr Anil Saxena  Escort Heart Institute and Research centr  Okhla Road, New Delhi - 110025, INDIA
New Delhi
DELHI 		 911147135000
911126825013
anil.saxena@hotmail.com 
Dr Ulhas Pandurangi  Madras Medical Mission  4-A, Dr J Jayalalitha Nagar, Mogappair, Chennai - 600037, INDIA
Chennai
TAMIL NADU 		 914426565961
914426565974
icvddoctors@mmm.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Artemis Health Sciences Institutional Review Board  Approved 
Independent Ethics Committee, Escort Heart Institute and Research Centre  Approved 
Institutional Ethics Committee Madras Medical Mission  Approved 
The Ethics Committee of Care institute of Medical Science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Bradyarrhythmia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation.

2. Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;

3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.  
 
ExclusionCriteria 
Details  1. Unable to be followed up by the participating centres for a period of two years;
2. Current device implanted for more than 15 days;
3. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physicians discretion);
4. Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Two-year all-cause mortality in patients implanted with PM - overall and stratified per patient characteristics, primary indications for implant, chosen pacing modality and device programming.  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Two-year cardiac cause mortality or first cardiac cause hospitalization according to physiologic pacing setting.

 		 2 Years 
Correlation between physiologic pacing setting and actual programmed pacing parameters.   2 Years 
Clinical development of indications to implantable-cardioverter defibrillator (ICD) or cardiac resynchronization device (CRT), and upgrade to ICD or CRT   2 Years 
Two-year all-cause mortality according to physiologic pacing setting  2 Years 
All cause hospitalizations according to physiologic pacing setting.   2 Years 
Device upgrade to implantable-cardioverter defibrillator (ICD) or cardiac
resynchronization device (CRT) 		 2 Years 
In the subgroup of patients without atrial fibrillation as primary rhythm disease
at enrolment: incidence at two years of documented episode of atrial tachycardia or fibrillation.  		 2 Years 
 
Target Sample Size   Total Sample Size="1730"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   23/03/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  11/09/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease. As of 07/Jun/2011, the trial is "closed to recruitment of participants".

 
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