A Phase 4 interventional study of Lenient Arm Restriction and Strict Arm Restriction in Post-Op Complication, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Prevention
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.
The purpose and objectives of this study is to investigate whether reducing the existing restrictions on patients post CIED will result in an improved patient experience post operatively and reduce complication rates. Results from this study will create standardized, postoperative arm restriction recommendations more uniform between various hospitals.
Hypothesis: The investigators hypothesize that outcomes of the post CIED implanted patients given lenient arm restriction will be non-inferior to those with prolonged arm restriction at reducing a combined primary endpoint of lead dislodgement, device infection, clinically significant pocket hematoma, upper limb DVT and frozen shoulder.
Clinical relevance: The investigators anticipate that patients with minimal (lenient) arm restriction will have similar postoperative complication rates compared to the prolonged arm restriction. Should this hypothesis be proven, this will greatly improve patient quality of life post CIED with less stringent restrictions.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 6,300 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Behavioral: Strict Arm Restriction
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)
Behavioral: Lenient Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation
Definitions of each component of primary outcome: 1. Lead dislodgement; dislodgment requiring surgical repair and dislodgement not occurring in the immediate post-op period (i.e., before the randomized intervention begins). Immediate post-op period is defined as from pocket closure to dislodgement suspected on first post- operative CXR (which is done 2-4hrs post-op). 2. Frozen shoulder in this study is defined as: Nursing or physician note mention of chronologically related (to index surgery) patient complaint of new or markedly worsened shoulder pain and/or restricted and stiffness of active and passive range of motion. 3. Upper arm venous thrombosis. 4. Clinically significant hematoma is defined as done in BRUISE CONTROL 2 trial: a hematoma that required re-operation and/or resulted in prolongation of hospitalization and/or required interruption of oral anticoagulation.
Time frame: 1 year
Rate of hematoma
1\. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)
Time frame: 1 year
Rate of lead dislodgement
2\. Rate of lead dislodgement (# of lead dislodgements / total number of new leads placed in each arm) separate by type of lead (RA vs. RV vs. LV)
Time frame: 1 year
Rate of frozen shoulder
3\. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)
Time frame: 1 year
Plan to share: No
Started Aug 2021 (actual). Primary completion is estimated for Aug 2029, 95 months after the start.
Of 45 non-industry phase 4 interventional studies under Postoperative Complications, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 32. This study's planned 95 months is above that.
Counting every sponsor, half of 46 studies reached it within 25 months; a quarter within 19 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ottawa Heart Institute Research Corporation →