| CTRI Number |
CTRI/2017/02/007780 [Registered on: 06/02/2017] Trial Registered Prospectively |
| Last Modified On: |
14/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post Market Registry |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients |
Scientific Title of Study
Modification(s)
|
Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients |
| Trial Acronym |
PATTERNS |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MDT16044 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
4th floor, Building no.12, Solitaire Corporate Park ,
Andheri Ghatkopar link road, Andheri East ,
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
4th floor, Building no.12, Solitaire Corporate Park ,
Andheri Ghatkopar link road, Andheri East ,
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
4th floor, Building no.12, Solitaire Corporate Park ,
Andheri Ghatkopar link road, Andheri East ,
Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd
1241, Solitaire Corporate Park
Building Number 12, 4th Floor
Andheri-Ghatkopar Link Road
Andheri (East), Mumbai – 400093
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Medtronic Inc |
| Address |
Cardiac Rhythm and Heart Failure research &Technology Department
8200 Coral Sea Street NE
Mounds View MN 55112 U.S.A.
18003282518 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| India Medtronic Pvt Ltd |
4th floor, Building no.12, Solitaire Corporate Park ,
Andheri Ghatkopar link road, Andheri East ,
Mumbai -400093
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna Jaiswal |
Fortis Escorts |
Room No. A-22,23,2nd Floor,
RC Building,Residential Tower
Okhla Road,New Delhi-25
New Delhi
DELHI |
911147135138
APARNAJASWAL@HOTMAIL.COM |
| Dr Ajit Thachil |
Lisie Hospital |
Lisie Hospital
PB 3053 Kochi 682018 Kerala India
Ernakulam
KERALA |
918606199666
docthachil@hotmail.com |
| Dr Balbir Singh |
Medanta-The Medicity |
Electrophysiology and Pacing, Sector 38, Gurgaon,
122001, Haryana India
Gurgaon
HARYANA |
911244141414
balbir.singh@medanta.org |
| Dr JPS Sawhney |
Sir Ganga Ram Hospital |
Research project Clinical research room 6th Floor Near Library
Rajendra Nagar
Delhi 110060 India
New Delhi
DELHI |
919810059773
911125861002
jpsswahney@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
| Institutional Ethics Commitee, Escorts |
Approved |
| Institutional Ethics Commitee, Lisie Hospital |
Approved |
| Institutional Ethics Commitee, PGIMER |
Submittted/Under Review |
| Institutional Ethics Committe, Medanta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All subjects implanted with Medtronic Cardiac devices with the Cardiac Compass® and OptiVol® feature can be evaluated for the study. , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
62.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject must be greater than 18 years of age.
2.Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
3.Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions
a) Heart failure
b) Chronic Obstructive Pulmonary Disease (COPD)
c) Renal deficiency
d) Atrial fibrillation
e) Diabetes
4. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
5. If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition. |
|
| ExclusionCriteria |
| Details |
Subject is unwilling or unable to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlate the device measured diagnostics parameters to any clinical event in subjects which lead to a major medication change, IV drug therapy, hospitalization, outside home treatment or any similar event. This will help outline the diagnostic changes seen in such subjects prior to acute clinical events. |
Study does not have any follow up visit and only looks retrospective events of patients and this data will be evaluated at the end of six months on the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
Phase of Trial
Modification(s)
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
02/03/2017 |
| Date of Study Completion (India) |
30/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The Medtronic study team will collaborate to publish the results of the study in an appropriate/highest impact local (Indian) and global publications. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
| The purpose of this study is to evaluate whether device diagnostics within Medtronic’s ICD, CRT and Pacemaker devices with the Cardiac Compass® and Optivol® feature can identify patients at risk for clinical events leading to hospitalization in Indian patients who are also very prone to co-morbid disease conditions like HF, Atrial fibrilation ,COPD, Diabetes and Renal dysfunction | |