| CTRI Number |
CTRI/2010/091/000179 [Registered on: 15/09/2010] |
| Last Modified On: |
19/02/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A pacemaker study evaluating two algorithms for better pacing management |
|
Scientific Title of Study
|
South Asia Study- Evaluation of VentriculAr Intrinsic Preference Plus VentricuLar AutoCapture Features In Dual ChAmber Pacemaker PaTiEnts (VALIDATE) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR-09-001-AP-LV |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Upendra Kaul |
| Designation |
|
| Affiliation |
|
| Address |
Fortis Flt. Lt. Rajan Dhall Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj
New Delhi
DELHI
110 070
India |
| Phone |
011- 47134231 |
| Fax |
011- 26825112 |
| Email |
upendra.kaul@fortishealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Upendra Kaul |
| Designation |
|
| Affiliation |
|
| Address |
Fortis Flt. Lt. Rajan Dhall Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj
New Delhi
DELHI
110 070
India |
| Phone |
011- 47134231 |
| Fax |
011- 26825112 |
| Email |
upendra.kaul@fortishealthcare.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Sumit Anand |
| Designation |
Clinical Manager |
| Affiliation |
St . Jude Medical India Pvt Ltd. |
| Address |
Property No. 100 1st Floor
Okhla Industrial Estate, Phase III
New Delhi
South
DELHI
110020
India |
| Phone |
918860661364 |
| Fax |
911142600110 |
| Email |
sanand@sjm.com |
|
|
Source of Monetary or Material Support
|
| St. Jude Medical Hong Kong Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
St Jude Medical Hong Kong Pvt Ltd |
| Address |
St. Jude Medical (HK) Ltd
Suite 1608 16/F Exchange Tower
33 Wang Chiu Road Kowloon Bay Kowloon Hong Kong SAR
|
| Type of Sponsor |
Other [Medical Device Industry- Global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Bangladesh |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rakesh Yadav |
AIIMS |
Ansari Nagar,-110029
New Delhi
DELHI |
01126593218
rakeshyadav123@yahoo.com |
| Dr. Prakash Kamath |
Amrita Institute of Medical Sciences and Research Centre |
Amrita Lane, AIMS Ponekkara Post,-682 041
|
91-484-2801234
91-484-2802020
drpkamath@aims.amrita.edu |
| Dr. Anil Mishra |
B. M. Birla Heart Research Centre |
1/1 National Library Avenue,-700027
Kolkata
WEST BENGAL |
91-33-22829314
dranilmishra@gmail.com |
| Dr. Sharada Kalavakolanu |
CARE Nampally |
Exhibition Grounds Road, Nampally,-500 001
Hyderabad
ANDHRA PRADESH |
91-040-30417777
91-040-30417488
bksharada@yahoo.com |
| Dr. Aparna Jaswal |
Escorts Heart Institute and Research Center |
Okhla Road,-110025
New Delhi
DELHI |
91-11-47135140
aparna.jaswal@fortishealthcare.com |
| Dr. Jitendra Singh Makkar |
Fortis Escorts Hospital, Jaipur |
Jawahar Lal Nehru Marg, Malviya Nagar,-302017
Jaipur
RAJASTHAN |
91-141-2547000
91-141-4008151
jitendra.singh@fortishealthcare.com |
| Dr Upendra Kaul |
Fortis Flt. Lt. Rajan Dhall Hospital |
Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj,-110070
South
DELHI |
911147134231
911126825112
upendra.kaul@fortishealthcare.com |
| Dr. Upendra Kaul |
Fortis Flt. Lt. Rajan Dhall Hospital |
Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj,-110070
New Delhi
DELHI |
91- 11- 47134231
91- 11- 26825112
upendra.kaul@fortishealthcare.com |
| Dr. Rajshekhar |
Yashoda Hospital |
Alexander Road,-500 003
|
91 40 - 2771 3333
91 40 - 2770 3999
lizarajasekhar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee, ESCORTS |
Approved |
| Ethical Committee, Fortis Hospital |
Approved |
| Institutional Ethical Committee, CARE Foundation |
Approved |
| Institutional Ethical Committee,AIIMS |
Approved |
| Institutional Ethical Committee,AIMS |
Approved |
| Institutional Ethical Committee,Yashoda Hospital |
Approved |
| Institutional Ethics Committee BM Birla |
Approved |
| Institutional Ethics Committee, BM Birla |
Approved |
| Institutional Ethics Committee, Escorts Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bradycardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VIP OFF and VAC OFF |
12 Months |
| Intervention |
VIP ON and VAC ON |
12 Months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have an indication for implantation of a dual chamber pacemaker according to the ACC / AHA / HRS guidelines
2. Patients must be able and willing to provide written informed consent to participate in the clinical study
3. Patient is geographically stable and willing to comply with the required follow-up schedule
|
|
| ExclusionCriteria |
| Details |
1. Patient has permanent AV block
2. Patient has persistent or permanent AF/AFL
3. Patient has pacemaker replacement
4. Patient is in NYHA Class IV
5. Patient is pregnant
6. Patient is less than 18 years old
7. Patient?s life expectancy is less than 12 months.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate that the Ventricular Intrinsic Preference (VIPTM) and Ventricular AutoCapture (VAC) features allow better RV pacing management, which helps in reducing the long-term incidence of unnecessary right ventricular (RV) pacing in patients with compromised / intact AV conduction. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of AV blocks; Percentage of VAC accuracy in ventricular pacing threshold measurements (Manual vs. Auto);Incidence of cardiovascular adverse events;Incidence of device related adverse events; Proportion of patients with symptoms |
3, 6 and 12 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/09/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Rakesh Yadav, MD, Aparna Jaswal, MD, FHRS, Sharada Kalavakolanu, MD, Prakash Kamath, MD, Shirish MS. Hiremath, MD, Dhiman Kahali, MD, Naresh K. Sood, MD, Anil Mishra, MD, Jitendra S. Makkar, MD, Upender Kaul, MD, FSCAI;Evaluation of the Ventricular Intrinsic Preference (VIPTM) and Ventricular AutoCapture (VAC) features in pacemaker patients: Results of the VALIDATE Study;6th aphrs CardioRhythm 2013;P3-016;i131 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, randomized, single-blinded, multicenter South Asia study. Patient who meets study inclusion/exclusion criteria will be enrolled and all baseline activities will be performed within 15 days post-implant (Enrollment-Baseline visit). Enrolled patients will be randomized within 45 Days post device implant. Data will be further collected at month 3, month 6 and month 12 post implant and at any unscheduled follow-up visits. The study had around 10 centers in India (approximately 70-75 patients) and Bangladesh. The clinical study has been submitted and final report has been submitted. |