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NCT Number: NCT04915261

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

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.

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Key information

Conditions

Post-Op Complication Hematoma Hemorrhage Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lenient Arm Restriction

Behavioral

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

Strict Arm Restriction

Behavioral

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

Primary outcomes

  1. A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation

    Time frame: 1 year

    Definitions of each component of primary outcome:

    • 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).
    • 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.
    • Upper arm venous thrombosis.
    • 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.

Secondary outcomes

  1. Rate of hematoma

    Time frame: 1 year

    • Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)

  2. Rate of lead dislodgement

    Time frame: 1 year

    • 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)

  3. Rate of frozen shoulder

    Time frame: 1 year

    • Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)

Study contacts

Contact information is provided by the study sponsor or research team.

Mehrdad Golian

CONTACT

[email protected]

613.696.7271

Tammy Knight

CONTACT

[email protected]

613.696.7000 ext. 19080

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: LENIENT

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Jun 7, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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