| CTRI Number |
CTRI/2016/04/006799 [Registered on: 05/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A prospective, randomized, controlled,
interventional, single-blinded, multi-center, post-market, global CRT in heart failure (HF) clinical study. |
|
Scientific Title of Study
|
AdaptResponse study: a prospective, randomized, controlled,
interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization
Therapy (CRT) in heart failure (HF) clinical study. |
| Trial Acronym |
AdaptResponse study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0, 1 Apr 2014 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park,
Building No 12, 6th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park,
Building No 12, 6th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Director Clinical and Medical Affairs |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park,
Building No 12, 6th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
1261, Solitaire Corporate Park,
Building No 12, 4th Floor,
Andheri-Ghatkopar Link Road, Andheri (E)Mumbai 400093
|
| Type of Sponsor |
Other [Private Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Saxena |
Fortis Escorts Heart Institute |
Okhla Road, CV Raman Marg, New Friends Colony, New Delhi, DL 110025
New Delhi
DELHI |
09810025511
Anil.saxena@hotmail.com |
| Dr Vanita Arora |
Max Devki Devi Hospital |
2, Press Enclave Rd, Saket, New Delhi, DL 110017
New Delhi
DELHI |
11-26515050
Vanita.arora@maxhealthcare.com |
| Dr Sanjay Mittal |
Medanta - the Medicity |
Medanta – The Medicity, Gurgaon, Haryana - 122001
Gurgaon
HARYANA |
91-1244141414
sanjay.mittal@medanta.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional review board of Max super specialty hospital |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| The Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subject is indicated for a CRT device according to local guidelines, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AdaptivCRT®, CardioSync®, and OptiVol® |
multi-programmable CRT-D devices
that monitors and regulates a patient’s heart rate by providing single or dual chamber rateresponsive
bradycardia pacing; RV-synchronized LV pacing or sequential biventricular pacing;
ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subject is willing to sign and date the study Patient Informed Consent (PIC) Form.
ï‚· Subject is indicated for a CRT device according to local guidelines.
ï‚· Subject has, minimally:
o Sinus Rhythm at time of enrollment.
o Left Bundle Branch Block (LBBB) as documented on an ECG (within 30
days prior to enrollment). Criteria16 for complete LBBB must include:
 Intrinsic QRS duration ≥140 ms (men) or ≥130 ms (women),
 QS or rS in leads V1 and V2,
and
 Mid-QRS notching or slurring in ≥2 of leads V1, V2, V5, V6, I, and
aVL.
o Intrinsic, normal AV conduction as documented on an ECG by a PR
interval less than or equal to 200ms (within 30 days prior to enrollment).
o Left ventricular ejection fraction less than or equal to 35% (documented
within 180 days prior to enrollment).
o NYHA class II, III or IV (documented within 30 days prior to enrollment)
despite optimal medical therapy. Optimal medical therapy is defined as
maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I,
ARB or Aldosterone Antagonist. |
|
| ExclusionCriteria |
| Details |
Subject is less than 18 years of age (or has not reached minimum age per local law).
ï‚· Subject is not expected to remain available for at least 2 years of follow-up visits.
ï‚· Subject has permanent atrial arrhythmias for which pharmacological therapy and/or
cardioversion have been unsuccessful or have not been attempted
ï‚· Subject is, or previously has been, receiving cardiac resynchronization therapy.
ï‚· Subject is currently enrolled or planning to participate in a potentially confounding drug or
device trial during the course of this study. Co-enrollment in concurrent trials is only
allowed when documented pre-approval is obtained from the Medtronic study manager
Subject has unstable angina, or experienced an acute myocardial infarction (MI) or
received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within
30 days prior to enrollment.
ï‚· Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or
valve replacement during the course of the study.
ï‚· Subject is post heart transplant (subjects on the heart transplant list for the first time are
not excluded).
ï‚· Subject has a limited life expectancy due to non-cardiac causes that would not allow
completion of the study.
ï‚· Subject is pregnant (if required by local law, women of child-bearing potential must
undergo a pregnancy test within seven days prior to device implant).
ï‚· Subject meets any exclusion criteria required by local law. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the composite of all-cause death and any intervention for heart
failure decompensation as adjudicated by the EAC. |
2 years after enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
None |
|
Target Sample Size
Modification(s)
|
Total Sample Size="3000"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "3797"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2015 |
| Date of Study Completion (India) |
02/11/2022 |
| Date of First Enrollment (Global) |
02/06/2014 |
| Date of Study Completion (Global) |
02/11/2022 |
|
Estimated Duration of Trial
|
Years="5"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective of the AdaptResponse Study is to test the hypothesis that
AdaptivCRT ® reduces the incidence of the combined endpoint of all-cause mortality and
intervention for heart failure decompensation, compared to standard CRT therapy, in
patients with a CRT indication, LBBB and normal AV conduction. Intervention for heart
failure decompensation (HF event) is defined as an event requiring “ invasive intervention
(i.e. IV diuretics, ultrafiltration, or equivalent) or inpatient hospitalizationâ€.
The study will be event driven, comparing the rate of first events. The study will continue
until a predetermined number of events have been observed, unless the DMC advises to
stop earlier.
The analysis will include all randomized patients and will follow the intent-to-treat principle.
A secondary analysis will be done including only the patients for whom the ECG Core
Laboratory confirmed the presence of LBBB. |