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Does Leaving the Hospital Earlier After Pacemaker Surgery Affect Recovery? A Study on Day 1 vs Day 3 Discharge

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080206
Enrollment
150
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 month

Sponsors

Dr Duggempudi Lakshmi Narayana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients eligible for CIED

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
1)Minor and Major complications at 1 month post discharge 2)Severity of Tricuspid Regurgitation at 6 monthsTimepoint: At 1 months and 6 months post discharge

Countries

India

Contacts

Public ContactDr Rajesh Vijayvergiya

Postgraduate Institute of Medical Education and Research

rajeshvijay999@hotmail.com9815221856

Outcome results

None listed

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