Actively Recruiting

Phase 4
All Genders
Healthy Volunteers
NCT04915261

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

Led by Ottawa Heart Institute Research Corporation · Updated on 2025-12-15

6300

Participants Needed

1

Research Sites

467 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing device surgery that includes implantation of at least one new endovascular lead
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

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Research Team

T

Tammy Knight

CONTACT

M

Mehrdad Golian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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