Comparing lenient and strict arm instructions after heart device surgery
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
This study tests whether allowing more movement with the arms after heart device surgery can improve recovery and reduce complications for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 6300 (estimated) |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT04915261 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include all patients undergoing surgery for the implantation of cardiac implantable electronic devices.
Not a fit: Patients undergoing standalone CIED generator replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients by allowing more freedom of movement after cardiac device surgery.
How similar studies have performed: Other studies have explored postoperative care protocols, but this specific comparison of lenient versus strict arm restrictions is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ottawa, Ontario
- 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
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.