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Search / Trial NCT06330675

Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT

Launched by CAPORALI ELENA · Mar 19, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pacemaker Implantable Cardioverter Defibrillator Early Mobilization Bed Rest

ClinConnect Summary

This clinical trial is looking at the best time for patients to start moving after getting a cardiac electronic device, like a pacemaker or defibrillator, implanted. Traditionally, patients have been told to stay in bed for a while after the procedure to reduce the risk of complications. This study aims to see if it's safe for patients to start moving just 4 hours after the procedure instead of waiting until the next day.

If you are at least 18 years old and have just received a new pacemaker or defibrillator, you may be eligible to participate. You would need to sign a consent form, agreeing to take part in the trial. During the study, you'll be monitored as you start moving at different times, and researchers will check to see if early movement affects your recovery. It's important to note that this trial is for patients who have not had any recent heart surgeries or device upgrades. The goal is to help determine the safest approach to recovery after these important procedures.

Gender

ALL

Eligibility 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

About Caporali Elena

Caporali Elena is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a commitment to ethical practices and rigorous scientific standards, the organization collaborates with leading researchers and institutions to design and conduct clinical trials that explore novel treatments across various therapeutic areas. Caporali Elena emphasizes transparency, patient safety, and data integrity, ensuring that all trials contribute valuable insights to the medical community and foster advancements in healthcare.

Locations

Lugano, , Switzerland

Patients applied

AG

1 patients applied

Trial Officials

Elena Caporali, MD

Principal Investigator

Cardiocentro Ticino Institute - EOC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported