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

A prospective, randomized controlled trial to compare the outcomes of same day discharge vs Day - 3 discharge following cardiac implantable electronic device implantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031077
Enrollment
200
Registered
2021-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I442- Atrioventricular block, complete Health Condition 2: I420- Dilated cardiomyopathy Health Condition 3: I453- Trifascicular block

Interventions

Intervention1: Same day discharge: Same day discharge following CIED implantation Control Intervention1: Discharge on day 3: Discharge on day 3 following CIED implantation

Sponsors

PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Pacing lead dislodgement 2. Infective complications Timepoint: 2 years

Secondary

MeasureTime frame
1. Pocket hematoma 2. Valve damage (TR-post procedure vs 6 months) Timepoint: 2 years

Countries

India

Contacts

Public ContactDr Rajesh Vijayvergiya

Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh

rajeshvijay999@hotmail.com09815221856

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026