| CTRI Number |
CTRI/2025/12/099980 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Heart Pacemaker Lead Placement Using Intracardiac Echocardiography Versus X-ray Guidance |
|
Scientific Title of Study
|
INTRACARDIAC ECHOCARDIOGRAPHY GUIDED VERSUS CONVENTIONAL LEFT BUNDLE BRANCH AREA PACING |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKILESHWAR REDDY |
| Designation |
DM CARDIOLOGY SECOND YEAR |
| Affiliation |
GOVIND BALLAH PANT HOSPITAL |
| Address |
ACACEMIC BLOCK , A BLOCK, ROOM NO 129 ,DEPARTMENT OF CARDIOLOGY, DELHI.
New Delhi
DELHI
110002
India |
| Phone |
9629951491 |
| Fax |
|
| Email |
akilesh1179@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKILESHWAR REDDY |
| Designation |
DM CARDIOLOGY SECOND YEAR |
| Affiliation |
GOVIND BALLAH PANT HOSPITAL |
| Address |
ACACEMIC BLOCK , A BLOCK, ROOM NO 129 ,DEPARTMENT OF CARDIOLOGY,GB PANT HOSPITAL DELHI.
DELHI
110002
India |
| Phone |
9629951491 |
| Fax |
|
| Email |
akilesh1179@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKILESHWAR REDDY |
| Designation |
DM CARDIOLOGY SECOND YEAR |
| Affiliation |
GOVIND BALLAH PANT HOSPITAL |
| Address |
ACACEMIC BLOCK , A BLOCK, ROOM NO 129 ,DEPARTMENT OF CARDIOLOGY, DELHI.
New Delhi
DELHI
110002
India |
| Phone |
9629951491 |
| Fax |
|
| Email |
akilesh1179@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GB PANT HOSPITAL |
| Address |
ACACEMIC BLOCK , A BLOCK, ROOM NO 129 ,DEPARTMENT OF CARDIOLOGY, GB pant hospital Delhi. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR JAMAL YUSUF |
GOVIND BALLAH PANT HOSPITAL |
ROOM NO 129, ACADEMIC BLOCK FIRST FLOOR, GB PANT HOSPITAL, DELHI.
New Delhi
DELHI |
9818289833
jamalyusuf72@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fluoroscopy guided left bundle branch area pacing |
comparator group will undergo fluoroscopy guided left branch area pacing. The lead is kept perpendicular to the septum in RAO view and screwed in LAO view. |
| Intervention |
Intracardiac echocardiography guided left bundle branch pacing |
study group will undergo Intracardiac echocardiography guided left bundle branch pacing and comparison group will undergo fluoroscopy guided left bundle branch pacing and both the groups are compared for the number of attempts taken to place the lead, total procedure and fluoroscopy duration, percentage of patients with selective and proximal left bundle branch pacing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years with septal thickness more than 8 mm with any of the following indications:
Complete heart block
Symptomatic sinus node dysfunction
Symptomatic second-degree heart block
LBBB with intermittent CHB
LBBB with severe LV dysfunction EF less than 35%.
|
|
| ExclusionCriteria |
| Details |
Surviving cardiac arrest caused by ventricular fibrillation.
Patients with congenital heart disease.
Patients with IVC anomalies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attempts taken to place the lead in the left bundle area and procedure and fluoroscopy duration. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
total procedure duration
fluoroscopy duration
proximal and selective left bundle branch pacing
|
QRS duration, LV ejection fraction, pacing parameters, |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will recruit 60 patients totally. 30 patients with intracardiac echocardiography guided left bundle branch area pacing and 30 patients with conventional fluoroscopy guided left bundle branch area pacing. The number of attempts taken to insert the lead in the left bundle area, total procedural duration, total fluoroscopy duration, QRS duration, left ventricular activation time, selective and proximal left bundle branch area pacing are measured. During 6 month follow up the lead parameters, ejection fraction, depth of lead from mitral and tricuspid annulus will be measured. |