Evaluating early mobilization after heart device implantation
Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial of Non-inferiority, Open and Controlled in Parallel Groups
This study is testing if getting up and moving just a few hours after getting a heart device, like a pacemaker, is safe for patients compared to staying in bed until the next day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 558 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT06330675 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety of early mobilization for patients who have undergone the implantation of cardiac electronic devices, such as pacemakers and defibrillators. Participants will be randomly assigned to either mobilize 4 hours post-procedure or follow the standard practice of bed rest until the next day. The study seeks to determine if early mobilization can be safely implemented without increasing the risk of complications. By comparing these two approaches, the research will provide insights into optimal postoperative care for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing new permanent pacemaker or implantable cardioverter-defibrillator implantation.
Not a fit: Patients who have had recent cardiac surgery or those requiring upgrades or revisions of implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery protocols, allowing patients to mobilize sooner after heart device implantation.
How similar studies have performed: While there is limited data on early mobilization post-CIED implantation, similar studies in other surgical contexts have shown promising results, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old * Signed informed consent form * New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD) Exclusion Criteria: * CIED implants after recent cardiac surgery * Upgrade or revision of implanted device * CRT implantation * Intraoperative complications
Where this trial is running
Lugano
- Cardiocentro Ticino Institute - EOC — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Elena Caporali, MD — Cardiocentro Ticino Institute - EOC
- Study coordinator: Elena Caporali, MD
- Email: elena.caporali@eoc.ch
- Phone: +41 (0)91 811 53 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.