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Can loosening arm rules after heart device surgery improve recovery?

NCT ID NCT04915261

Symptom relief Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study compares lenient versus strict arm restrictions for 6,300 patients who receive a heart device like a pacemaker. The goal is to see if fewer restrictions reduce complications such as lead dislodgement, frozen shoulder, blood clots, and hematomas, while also improving patient comfort. Patients will be randomly assigned to one of two instruction sets, which will change every 8 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
arm restriction instructions (lenient vs strict)
What this could lead to
If lenient restrictions work as well or better, patients could have less pain, anxiety, and faster recovery after heart device surgery.
What could go wrong
This is a behavioral study, not a drug trial, so the impact is limited to post-surgery care. Results may not apply to all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 6,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hematoma Infections Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-op complication

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

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