NCT04915261 A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
| NCT ID | NCT04915261 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Post-Op Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,300 participants |
| Start Date | 2021-08-19 |
| Primary Completion | 2029-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 6,300 participants in total. It began in 2021-08-19 with a primary completion date of 2029-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery. Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices. Instructions within both arms of this study are considered within reasonable practice in Canada. All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions. All patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24/7 on call nursing program.
Eligibility 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
Contact & Investigator
David Birnie
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT04915261 clinical trial?
This trial is open to participants of all sexes, studying Post-Op Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04915261 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04915261 currently recruiting?
Yes, NCT04915261 is actively recruiting participants. Contact the research team at tknight@ottawaheart.ca for enrollment information.
Where is the NCT04915261 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT04915261 clinical trial?
NCT04915261 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is David Birnie at Ottawa Heart Institute Research Corporation. The trial plans to enroll 6,300 participants.