| CTRI Number |
CTRI/2024/05/067950 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying how using a certain type of pacemaker affects how well the right side of your heart works. |
|
Scientific Title of Study
|
Study of impact of dual chamber pacing on right atrial function. |
| 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 Harshvardhan N M |
| Designation |
Cardiology Registrar |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
KMC Hospital - Manipal, Department of Cardiology,
Manipal, Udupi
Blue berry woods apartment, Flat No. 1303, Opposit bacchus Inn, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7829884191 |
| Fax |
|
| Email |
harsh135018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukund A Prabhu |
| Designation |
Associate Professor |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
Department of Cardiology, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshvardhan N M |
| Designation |
Cardiology Registrar |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION |
| Address |
KMC Manipal, Department of Cardiology
Blue berry woods apartment, Flat 1303, Opposite Bacchus Inn, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7829884191 |
| Fax |
|
| Email |
harsh135018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Kasturba Medical College and Hospital, Tiger Circle, Madhava nagar, Manipal, Udupi, Karnataka - 576104 |
| 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 Harshvardhan N M |
KMC Manipal |
Department of Cardiology,(room no 37), KMC Hospital
Udupi
KARNATAKA |
7829884191
harsh135018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and Kasturba Hospital Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I442||Atrioventricular block, complete, (2) ICD-10 Condition: I459||Conduction disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with dual chamber pacemaker
Patient with RV pacing more than 40% |
|
| ExclusionCriteria |
| Details |
Structural heart disease
Previous DDDR
Previous cardiac surgerires or interventions
Dysfunctional pacemakers
Presence of documented cardiac arrhythmias
Known RV dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The changes in the right atrial morphometric and functional parameters after dual chamber pacemaker implantation. |
RA structure and function will be assessed through echo on 1-2 days before , 1-2 days after and 1 month post pacemaker implantation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Right Ventriuclar dysfunction & its co relation with right atrial functional & morphometric parameters. |
RV function will be assessed through echo on 1-2 days before, 1-2 days after & 1 month post pacemaker implantation. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/06/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
At the outset, we will obtain necessary approvals, including IRC (Institutional Review Committee), IEC (Institutional Ethics Committee) approval, and registration with CTRI (Clinical Trials Registry - India). Our study will focus on patients aged 18 years and above, who undergo dual chamber pacemaker implantation. Before the study, we will approach these patients and provide a detailed explanation of the research. Upon their understanding and agreement, informed consent will be obtained. Demographic details and clinical data and treatment receiving will be collected using proforma. Echocardiography will be done as a standard care in which RA size, RA area, RV wall thickness, RVOT diameter, TAPSE, IVC diameter and E/A ratio will be measured. Speckle-tracking echo will be done to measure RA strain, Strain rate and RV strain. Echocardiography will be done at 3 different dates. First echo will be done 1-2 days prior to pacemaker implantation. Second echo will be done 1-2 days after the pacemaker implantation and the third echo will be done after 1 month of procedure during follow-up. Patients with RV pacing of more than 40% will be included in this study. There will be no need for additional visits or follow-up in this study. |