Comparing lenient and strict arm instructions after heart device surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of lenient versus strict arm restrictions on patients who have undergone cardiac device surgery. It aims to determine if reducing arm restrictions can enhance patient experience and lower complication rates post-operatively. The study employs a cluster crossover randomized design to compare outcomes between the two groups, focusing on complications such as lead dislodgement and device infection. The goal is to establish standardized postoperative arm restriction recommendations across hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* all patients undergoing device surgery which includes implantation of at least one new endovascular lead

Exclusion Criteria:

* Standalone CIED generator replacement
* Subcutaneous implantable cardioverter defibrillators
* Leadless endocardial pacemakers
* Temporary permanent pacemakers

Where it's running

• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: David Birnie — Ottawa Heart Institute Research Corporation
• Study coordinator: Tammy Knight
• Email: tknight@ottawaheart.ca
• Phone: 613.696.7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.