Recruiting

Arm Restrictions

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT04915261

Conditions

Post-Op Complication

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Lenient Arm Restriction

Strict Arm Restriction

Study Details

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.

Conditions

Post-Op Complication

Study ID

NCT04915261

Start date

Aug 19, 2021

Status verified date

Jul, 2026

Completion date

Aug 1, 2030

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Strict Arm

The strict arm group will be given the following restrictions. These restrictions are the current institutional protocol at the study site and falls within common practice pattern across Canada:

1. No arm or shoulder movement x 24 hours
2. No movement of affected arm overhead x 8 weeks
3. No lifting anything heavier than 5 lbs (2.5kg) and avoid any kind of sports or other vigorous activities including golf, tennis, swimming or sweeping x 8 weeks
4. Avoid any kind of shovelling x 8 weeks

active comparator: Lenient Arm

The lenient arm restriction group will be given the following restrictions. The justification for the selected lenient restriction is based on the current recommendations at a Canadian center as identified by the national survey:

1. No shoveling 7 days,
2. No golfing/swimming/tennis 14 days
3. No other restrictions (overhead activity and weight lifting no limitation)

Interventions

Lenient Arm Restriction

The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Strict Arm Restriction

The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Primary outcome measure

  • A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Tammy Knight

613.696.7000tknight@ottawaheart.ca

Mehrdad Golian

613.696.7271mgolian@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Tammy Knight

6136967000tknight@ottawaheart.ca

Mehrdad Golian

6136967000mgolian@ottawaheart.ca

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Cardiac
  • Implantable
  • Electronic
  • Device
  • Arm
  • Restriction
  • Post-operative
  • infection
  • dislodgement
  • hematoma
  • DVT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-07-07.