Comparison of the outcomes of same day discharge vs Day - 3 discharge following cardiac implantable electronic device implantation

Not yet recruiting

Conditions: Atrioventricular block, complete, (2) ICD-10 Condition: I420||Dilated cardiomyopathy, (3) ICD-10 Condition: I453||Trifascicular block,

Registration Number: CTRI/2021/02/031077

Lead Sponsor: PGIMER CHANDIGARH

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

All adult patients (>18 years old) with indication to CIED implantation according to contemporary guidelines.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pacing lead dislodgement	2 years
2.Infective complications	2 years

Secondary Outcome Measures

Name	Time	Method
1.Pocket hematoma	2.Valve damage (TR-post procedure vs 6 months)

Trial Locations

Locations (1): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Dr Rajesh Vijayvergiya
Principal investigator
09815221856
rajeshvijay999@hotmail.com