| CTRI Number |
CTRI/2021/02/031077 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the outcomes of same day discharge vs Day - 3 discharge following cardiac implantable electronic device implantation |
|
Scientific Title of Study
|
A prospective, randomized controlled trial to compare the outcomes of same day discharge vs Day - 3 discharge following cardiac implantable electronic device implantation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh |
| Address |
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh |
| Address |
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
CHANDIGARH
160012
India |
| Phone |
09815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Vijayvergiya |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh |
| Address |
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12
CHANDIGARH
160012
India |
| Phone |
09815221856 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER, ACC, 3RD FLOOR, Cardiology office
SECTOR 12 |
| 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 Rajesh Vijayvergiya |
PGIMER |
PGIMER, ACC, 3RD FLOOR,
SECTOR 12
Chandigarh
CHANDIGARH |
09815221856
rajeshvijay999@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (PGIMER) |
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: I420||Dilated cardiomyopathy, (3) ICD-10 Condition: I453||Trifascicular block, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Discharge on day 3 |
Discharge on day 3 following CIED implantation |
| Intervention |
Same day discharge |
Same day discharge following CIED implantation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (>18 years old) with indication to CIED implantation according to contemporary guidelines |
|
| ExclusionCriteria |
| Details |
1. CIED replacement or upgrading,
2. Cardiac resynchronization therapy (CRT) device implantation,
3. Disabling conditions causing physical and mobility impairment (e.g. severe muscular dystrophies, spinal cord lesions)
4. Autoimmune diseases,
5. Antibiotic use for any reason (including patients who were chronically immunocompromised),
6. Any surgery within the prior 30 days,
7. Previous infection treated in the prior 30 days,
8. Other antibiotic prophylaxis indications (eg, patients with prosthetic heart valves)
9. Hemodynamically unstable, intubated patients
10. Patients with major intra-procedural complications such as pneumothorax, cardiac perforation/pericardial tamponade, haemothorax, myocardial infarction, peripheral embolus, stroke, and deat
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pacing lead dislodgement
2. Infective complications
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pocket hematoma
2. Valve damage (TR-post procedure vs 6 months)
|
2 years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2021 |
| 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="2"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, single centre, open label trial assessing the feasibility and safety of same day discharge following CIED implantation in comparison to discharge on day 3. Primary end-points of the study includes pacing lead dislodgement and infective complications. Secondary end-points were pocket hematoma and valve damage. |