| CTRI Number |
CTRI/2011/05/001746 [Registered on: 19/05/2011] Trial Registered Prospectively |
| Last Modified On: |
18/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to analyse safety, effectiveness and efficiency of new EVIA pacemaker family during routine pacemaker follow up after implantation. |
|
Scientific Title of Study
|
REgistry for PaceMakers
Offering Therapy Enhancement EVIA |
| Trial Acronym |
REMOTE-EVIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BA095 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prabhas Goswami |
| Designation |
Assistant Manager- Marketing & Clinical Affairs |
| Affiliation |
BIOTRONIK Medical Devices India Private Limited |
| Address |
BIOTRONIK Medical Devices India Private Limited
101-106, Plot 14, LSC, Kalkaji
New Delhi
DELHI
110019
India |
| Phone |
911140587850 |
| Fax |
911140587855 |
| Email |
prabhas.goswami@biotronik.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bina Naik |
| Designation |
Medical and Managing Director |
| Affiliation |
Vibgyor Scientific Research Pvt Ltd. |
| Address |
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 |
Mr Prabhas Goswami |
| Designation |
Assistant Manager- Marketing & Clinical Affairs |
| Affiliation |
BIOTRONIK Medical Devices India Private Limited |
| Address |
BIOTRONIK Medical Devices India Private Limited
101-106, Plot 14, LSC, Kalkaji
New Delhi
DELHI
110019
India |
| Phone |
911140587850 |
| Fax |
911140587855 |
| Email |
prabhas.goswami@biotronik.com |
|
|
Source of Monetary or Material Support
|
| BIOTRONIK SE Co KG
Woermannkehre 1 12359 Berlin Germany
|
|
|
Primary Sponsor
|
| Name |
BIOTRONIK SE Co KG |
| Address |
Woermannkehre 1 12359 Berlin Germany
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BIOTRONIK Medical Devices India Private Limited |
101-106, Plot 14, LSC, Kalkaji
New Delhi
110019
India |
|
|
Countries of Recruitment
|
Austria
Belgium
Czech Republic
Denmark
Germany
India
Sweden
Switzerland
United Kingdom |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Naik |
Care Institute of Medical Scineces |
Nr. Sukan Mall, Off Science city Road, Sola, Ahmedabad- 380060
Ahmadabad
GUJARAT |
917927712771
917927712777
ajay.naik@cims.me |
| Dr Anil Saxena |
Escort Heart Institute and Research Center |
Okhla Road, New Delhi-110025
New Delhi
DELHI |
911147135000
911126825112
anil.saxena@hotmail.com |
| Dr Mohan Nair |
Max Hospital |
108 A, Indraprastha Extension
Patparganj, New Delhi 110 092.
New Delhi
DELHI |
911143033333
911143170886
mohancardio@gmail.com |
| Dr Vanita Arora |
Max Hospital |
2, PRESS ENCLAVE ROAD, SAKET, NEW DELHI-110017
New Delhi
DELHI |
919818474003
vanita.arora@maxhealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Escort Heart Institute and Research Center |
Approved |
| Institutional Ethics Committee of Max Super Speciality Hospital |
Approved |
| Institutional Review Board of Max Super Speciality Hospital |
Approved |
| The Ethics Committee of Care Institute of Medical Scineces |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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. The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent.
2. EVIA pacemaker implantation performed within 6 weeks prior to enrollment. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years.
2. Participation in another clinical study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of (Serious) pacemaker - related Adverse Device Effects |
12 +/- 2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differences between automatic, manual, and initial data after pacemaker interrogation of P/R wave amplitude, A/V threshold and A/V lead impedance data |
12 +/- 2 Months |
| Number of patients with successful A/V Capture Control during the study |
12 +/- 2 Months |
| Percentage of ventricular pacing with respect to the programming in two-chamber pacemakers: AV dalay, IRS plus, DDD(R)-ADI(R)mode/ Vp suppression |
12 +/- 2 Months |
| Calculated battery lifetime and benefit of this tool based on the investigators judgment |
12 +/- 2 Months |
| Producing the intended results based on the investigators judgment: A/V Auto Sensing, A/V Capture Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service center III & traffic light concept, IEGM-online HD |
12 +/- 2 Months |
| Number of patients without additional automatic and/or manual avaluation of sensing, threshold, and lead Impedance data after pacemaker interrogation |
12 +/- 2 Months |
| Saving of time based on the investigators judgment: A/V Sensing, A/V Capture, Control, Vp suppression/ DDD(R)-ADI(R) mode, IRS plus, Home Monitoring service cente III & traffic light concept, IEGM-online HD |
12 +/- 2 Months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
19/05/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The publication rights in regard to all patient data belong to the Coordinating Clinical Investigator. Additional authors are determined by the volume and quality of data at the remaining Investigational sites. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
REMOTE-EVIA (REgistry for PaceMakers Offering Therapy Enhancement - EVIA) has been designed to analyze safety, effectiveness, and efficiency of the new EVIA pacemaker family during routine pacemaker follow-up after implantation. The investigators are asked to document the routine pacemaker follow-up and evaluate some pacemaker and Home Monitoring functions. The pacemaker therapy will be investigated based on the data obtained between a follow up not later than a follow-up not later than 6 weeks and a follow-up 12 +/- 2 months after pacemaker implantation. There is no upper limit of age for the inclusion of patients in the study.
|