| CTRI Number |
CTRI/2025/02/080262 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how pacemaker lead position will effect back flow of blood in right heart using 4D heart scan |
|
Scientific Title of Study
|
Assessing the influence of RV lead position on tricuspid regurgitation using 4 d echocardiography |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganesh G Kamath |
| Designation |
Post graduate pursuing MSc.Echocardiography |
| Affiliation |
Manipal college of health professions |
| Address |
Room no.212, Department of cardiovascular technology , Manipal college of health professions , Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8197183558 |
| Fax |
|
| Email |
GANESHKAMATH7890@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mukund A prabhu |
| Designation |
Associate professor |
| Affiliation |
Manipal college of health professions |
| Address |
Room no. 34, Department of cardiology , Kasturba hospital , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
98951 37146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh G Kamath |
| Designation |
Post graduate pursuing MSc.Echocardiography |
| Affiliation |
Manipal college of health professions |
| Address |
Room no.212, Department of cardiovascular technology , Manipal college of health professions , Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8197183558 |
| Fax |
|
| Email |
GANESHKAMATH7890@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education Manipal |
| Address |
Room no. 34 , Department of cardiology , 3rd floor , Kasturba medical college and hospital, Tiger circle road, Madhav nagar , Manipal.
576104, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mukund A Prabhu |
Kasturba M1 edical College and Kasturba Hospital |
Department of cardiology , Room no.34,third floor , kasturba hospital , manipal, udupi , 576104
Udupi
KARNATAKA |
98951 37146
mukundaprabhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z950||Presence of cardiac pacemaker, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing permanent pacemaker implantation(PPI) |
|
| ExclusionCriteria |
| Details |
Structural heart disease
Dysfunctional pacemakers
Previous cardiac surgeries/interventions
Poor echo window |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tricuspid regurgitation
Lead position in fluoroscopy and 4D echocardiography
Lead traversing through tricuspid valve in 4D echocardiography |
At the recruitment
At three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RA And RV morphometric and functional parameters |
At the recruitment
At three months |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study will be conducted in the Department of Cardiology at Kasturba Hospital, Manipal, following IEC approval and CTRI registration. It aims to explore the effects of right ventricular (RV) lead positioning on tricuspid regurgitation (TR) and right atrial (RA) function using 4D echocardiography. The primary objective will be to determine how RV lead placement influences TR. Secondary objectives will include comparing the accuracy of 4D echocardiography and fluoroscopic landmarks in identifying the pacing site, as well as evaluating the acute and short-term effects of permanent pacemaker implantation (PPI) on RA and RV function. Participants will undergo echocardiographic assessments 1-2 days before the procedure, immediately after implantation, and at a three-month follow-up. Additionally, post-implantation, the study will document fluoroscopic lead placement and landmarks. This research will address the gap in understanding the impact of RV lead positioning on TR and RA changes, with the potential to reveal whether RA dysfunction precedes RV issues, thereby enhancing clinical management for symptomatic patients with no further visits or follow-ups required beyond these assessments. |