| CTRI Number |
CTRI/2022/10/046216 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical and echocardiographic outcomes of left bundle area pacing |
|
Scientific Title of Study
|
"CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES AFTER CONDUCTION SYSTEM PACING: A MULTI-CENTRIC OBSERVATIONAL STUDY" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K K Narayanan Namboodiri |
| Designation |
Professor, Dept.of.Cardiology, SCTIMST |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology,Trivandrum |
| Address |
Room No:45, Ist Floor,
Electrophysiology Division
Department of Cardiology
SCTIMST, Jai Nagar W, Rd, Chalakkuzhi,
Trivandrum,Kerala,Pin:695011
Kerala,
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447223340 |
| Fax |
|
| Email |
kknnamboodiri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K K Narayanan Namboodiri |
| Designation |
Professor, Dept.of.Cardiology, SCTIMST |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology,Trivandrum |
| Address |
Room No:45, Ist Floor,
Electrophysiology Division
Department of Cardiology
SCTIMST, Jai Nagar W, Rd, Chalakkuzhi,
Trivandrum,Kerala,Pin:695011
Kerala,
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447223340 |
| Fax |
|
| Email |
kknnamboodiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SreelekshmiM |
| Designation |
JRF |
| Affiliation |
SCTIMST,TRIVANDRUM |
| Address |
Room No 15
E.code:4131
Dept. of.Cardiology
SCTIMST,
Jai Nagar W Rd, Chalakkuzhi,
Thiruvananthapuram, kerala,
pin:695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
6381035991 |
| Fax |
|
| Email |
sreelekshmiprajeeth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medtronic Inc |
| Sree Chitra Tirunal Institute for Medical Sciences and Technology,Trivandrum,kerala |
|
|
Primary Sponsor
|
| Name |
Medtronic Inc |
| Address |
8200 Coral Sea Street NE,
Mounds View,
Minnesota 55112 |
| Type of Sponsor |
Other [Medical Device company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKKNarayanan Namboodiri |
SCTIMST,Trivandrum |
Room No:45
Ist floor
Electrophysiology Division
Department of Cardiology
Jai nagar, W Rd
Chalakkuzhi
Thiruvananthapuram, Kerala,
695011
Thiruvananthapuram
KERALA |
9447223340
kknnamboodiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,SCTIMST,Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I455||Other specified heart block, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged > 18 years who were subjected to either,
1. permanent left bundle branch area pacing for the atrioventricular block or bundle branch
block, irrespective of the left ventricular ejection fraction (This subgroup essentially
represents the CRT-P and Brady populations.), or
2. Those who had left bundle -optimized CRT |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent
2. Planned for conventional pacing or any form of physiological pacing other than LBB
pacing
3. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the
pacing characteristics, clinical and echocardiographic outcomes of adult patients who require permanent
pacemaker implantation for AV block/Bundle branch block and are taken up for conduction system pacing
techniques(His bundle pacing/Left bundle branch pacing) as per their clinical considerations |
Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the composite endpoint among patients with a prespecified burden of ventricular pacing and individual outcomes. |
Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/10/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
publication details will be provided once available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, Multi-centre, observational study of consecutive adult patients who require permanent pacemaker implantation for AV block/Bundle branch block and are taken up for conduction system pacing techniques ( His bundle pacing/Left bundle branch pacing)as per their clinical considerations to determine the pacing characteristics, clinical and echocardiographic outcomes during short term follow up. |