| CTRI Number |
CTRI/2025/02/080206 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does Leaving the Hospital Earlier After Pacemaker Surgery Affect Recovery? A Study on Day 1 vs Day 3 Discharge
|
|
Scientific Title of Study
|
A prospective, randomized controlled trial to compare the outcomes of same day vs Day 3 discharge following cardiac implantable electronic device implantation.
|
| 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 Duggempudi Lakshmi Narayana |
| Designation |
Post Graduate |
| Affiliation |
Post graduate institute of medical education and research |
| Address |
room no 1032
ground floor,Advanced cardiac centre,Post graduate institute of medical education and research,Chandigarh.
Sector 12,
Chandigarh
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7036735943 |
| Fax |
|
| Email |
lakshminarayana127@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor of Cardiology |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No. 3002, 3rd Floor, C Block
Department of Cardiology, Advanced Cardiac Centre
PGIMER, Madhya Marg, Opposite Panjab University
Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor of Cardiology |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room No. 3002, 3rd Floor, C Block
Department of Cardiology, Advanced Cardiac Centre
PGIMER, Madhya Marg, Opposite Panjab University
Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research ,CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
Dr Duggempudi Lakshmi Narayana |
| Address |
romm no 1032
ground floor,Advanced cardiac centre,Postgraduate Institute of Medical Education and Research,chandigarh,
160012,
INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Duggempudi Lakshmi Narayana |
Postgraduate Institute of Medical Education and Research |
romm no 1032
ground floor,Advanced cardiac centre,Postgraduate Institute of Medical Education and Research,chandigarh,
160012,
INDIA
Chandigarh
CHANDIGARH |
7036735943
lakshminarayana127@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER |
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 |
| Intervention |
Day 1 discharge protocol |
Patients discharged on Day 1 following permanent pacemaker implantation, with appropriate counseling and follow-up plans.There is a follow up period of 6 months after discharge . |
| Comparator Agent |
Day 3 discharge protocol |
Patients discharged on Day 3 following permanent pacemaker implantation, following standard care protocols.There is a follow up period of 6 months after discharge. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients eligible for CIED |
|
| ExclusionCriteria |
| Details |
1. Critical Complications Post-Procedure:
Significant hematoma at the insertion site.
Lead dislodgment or repositioning issues.
Suspected or confirmed infection.
2. Re-Implantation Cases:
Patients undergoing pacemaker replacement or upgrade to CRT/ICD.
3. Pre-Existing Severe Comorbidities:
Advanced renal failure requiring dialysis.
Uncontrolled diabetes with complications.
Active malignancy.
4. Pregnancy:
Pregnant or lactating women.
5. Non-Compliance:
Patients unlikely to adhere to follow-up protocols.
Patients unable to comprehend study requirements or provide consent.
6. Coexistent Cardiac Complications:
Severe heart failure (NYHA Class III-IV).
Severe valvular heart disease.
7. Participation in Other Trials:
Patients enrolled in another clinical trial that could affect outcomes. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to assess the Safety,Quality of life and Economic Impact of same-day discharge versus a standard 3-day discharge following cardiac implantable electronic device (CIED) implantation. |
The primary objective of this study is to assess the Safety,Quality of life and Economic Impact of same-day discharge versus a standard 3-day discharge following cardiac implantable electronic device (CIED) implantation.
Quality of life is assessed at the time of discharge.Safety outcomes are assessed at 6 months .Economic impact at the time of discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Minor and Major complications at 1 month post discharge
2)Severity of Tricuspid Regurgitation at 6 months |
At 1 months and 6 months post discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/02/2025 |
| 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)
|
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
|
Aims to determine safety,quality of life ,economic impact between day 1 versus day 3 discharge. |