| CTRI Number |
CTRI/2013/11/004148 [Registered on: 19/11/2013] Trial Registered Prospectively |
| Last Modified On: |
19/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Autonomic Regulation Therapy for treatment of Heart Failure - Extension Study |
Scientific Title of Study
Modification(s)
|
Extension 5 Hz Study of Neural Regulation Therapy on Myocardial Function in Heart Failure (Extension ENCORE 5 Hz). |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| C-06, Version 2.0 Dated 30 August 2016 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Vatika Mindscapes Tower B,
6th Floor, Plot 12/2,
Sector 27 D,
Faridabad
HARYANA
121003
India |
| Phone |
91-8800799887 |
| Fax |
129-6613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head - Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Vatika Mindscapes Tower B,
6th Floor, Plot 12/2,
Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
91-9810979215 |
| Fax |
129-6613520 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Cyberonics, Inc. 100 Cyberonics Blvd. Houston, Texas 77058 USA |
|
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Primary Sponsor
|
| Name |
Cyberonics Inc |
| Address |
100 Cyberonics Blvd. Houston, Texas 77058 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| JSS Medical Research India Private Limited |
Vatika Mindscapes Tower - B, 6th Floor, Plot 12/2, Sectore 27D, Faridabad - 121003, Haryana, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhagvathula Kutumba Srinivasa Sastry |
Care Hospitals |
Room# 14, OPD block,
Cardiology department, Exhibition Grounds Road, Nampally, Pin Code – 500001
Hyderabad
ANDHRA PRADESH |
9849599888
bksshastri@hotmail.com |
| Dr Rajendra Kumar Premchand |
Krishna Institute of Medical science |
Room #46 , 3rd Floor, Block 3, Cardiology department , #1-8-31/1, Minister Road, Secunderabad - 500003, India
Hyderabad
ANDHRA PRADESH |
9848029443
kumarpre@hotmail.com |
| Dr Kamal Sharma |
Sanjivani Super Speciality Hopsitals Pvt.Ltd. |
Room # 4, Ground Floor,
Cardiology Department,
1, Uday Park Society, Nr.Sunrise Park, Vastrapur,
Pin Code – 380015
Ahmadabad
GUJARAT |
9925195662
kamalsharma1975@rediffmail.com |
| Dr Rufino Monteiro |
Vintage Hospital Premises |
Ground Floor,
Cardiology Department
Building No- 2, Near Caculo Mall, Panaji.
North Goa
GOA |
9822100328
rufino@sify.com |
| Dr Rajasekhar V |
Yashoda Hospital (Behind Harihara Kalabhavan) |
Room No 159, OP-V, First Floor, S.P. Road, Secunderabad-500003, Telangana, India
Hyderabad
ANDHRA PRADESH |
9949825483
dr.rajasekharvarada@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Care Foundation, Care Hospital, Road No.1,Banjara Hills,Hyderabad-500 034 |
Approved |
| Institutional Ethics Committee, Yashoda Group of Hospital Hyderabad. Yashoda Hospital, Behind Harihara kalabhavan |
Approved |
| KIMS Intuitional Ethics Committee, #1-8-31/1, Minister Road, Secunderabad Institutional Ethics Committee, Yashoda Group of Hospital Hyderabad 500003, Hyderabad |
Approved |
| Sanjivani Hospital Ethics Committee,1 New Uday Park Society, Near Sunrise Park,Vastrapur, Ahemdabad-380015 |
Approved |
| Vintage Institutional Ethics Committee, Office c/o: Vintage Hospital and Medical Research Centre Pvt Ltd, Caculo Enclave, St.Inez, Panaji, Goa 403001, India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Heart Failure, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Implantable VNS Therapy System |
Open-label safety follow-up study. Patients with symptomatic heart failure who have had a cervical VNS implantation on either the left side or right side on ANTHEM-HF followed up to under ENCORE study & the ENCORE 5Hz Extension study (Lead-in study). After completion of the ENCORE 5 Hz Extension study, continuous data collection will be done at baseline, 6 months, and 12 months. Safety will be determined by the incidence of device-related complications. Efficacy will be determined by heart failure measurements such as left ventricular end systolic volume (LVESV) and left ventricular end systolic diameter (LVESD), and ejection fraction (EF). |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients enrolled in the study must meet all of the following criteria:
1. Willing and capable of providing informed consent
2. Completed the ENCORE Extension study (18-month study)
|
|
| ExclusionCriteria |
| Details |
Patients who meet any of the following criteria are not eligible to be enrolled in the study:
1. Patients with a life expectancy of less than 12 months per physician judgement.
2. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
3. Patients scheduled for Cardiac Resynchronization Therapy (CRT) in the next 6 months
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The primary safety objective will be the incidence of device-related complications.
The primary efficacy objective is to evaluate the change in measures of cardiac function (LVESV and EF) |
Baseline, 6 and 12 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 6-minute walk |
Baseline, 6 and 12 months |
| Quality of Life based on patient questionnaire |
Baseline, 6 and 12 months |
| NYHA Class |
Baseline, 6 and 12 months |
| Heart rate variability (HRV) |
Baseline, 6 and 12 months |
Blood biomarkers (brain natriuretic peptide,
NT-proBNP, creatinine |
Baseline, 6 and 12 months |
| Left Ventricular End Systolic Diameter (LVESD) |
Baseline, 6 and 12 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/11/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A followup safety study to see the long-term effect of safety and efficacy of Cyberonics VNS Therapy System for the treatment of symptomatic heart failure for an additional 6 months.
RefCTRI Number for the main study is CTRI/2012/05/002681 |