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

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ClinicalTrials.gov Identifier: NCT04915261
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
David Birnie, Ottawa Heart Institute Research Corporation

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 7 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 our device clinic and 24/7 on call nursing program.


Condition or disease Intervention/treatment Phase
Post-Op Complication Behavioral: Lenient Arm Restriction Behavioral: Strict Arm Restriction Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The trial is a single centre non-inferiority cluster crossover trial. Arm restriction protocol will cross over every 8 months with a one month run-in then 7 months of data collection.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2025

Arm Intervention/treatment
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
Behavioral: Strict Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

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)
Behavioral: Lenient Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.




Primary Outcome Measures :
  1. Occurring within 52 weeks of index surgery a composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation 5) infection [ Time Frame: 1 year ]

    Definitions of each component of primary outcome:

    1. Lead dislodgement; dislodgment requiring surgical repair
    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
    5. Infection will be categorized into three categories pocket infection, blood stream infection and endocarditis


Secondary Outcome Measures :
  1. Rate of hematoma [ Time Frame: 1 year ]
    1. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)

  2. Rate of lead dislodgement [ Time Frame: 1 year ]
    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)

  3. Rate of frozen shoulder [ Time Frame: 1 year ]
    3. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)

  4. Rates of clinically significant pocket infection [ Time Frame: 1 year ]
    5. Rates of clinically significant pocket infection (# of clinically significant device related infections / total number of procedures performed for each arm)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients undergoing device surgery which includes implantation of at least one new endovascular lead

Exclusion Criteria:

  • Standalone CIED generator replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915261


Contacts
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Contact: Tammy Knight 613.696.7000 ext 19080 tknight@ottawaheart.ca
Contact: Mehrdad Golain 613.696.7271 mgolain@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Tammy Knight    6136967000 ext 19080    tknight@ottawaheart.ca   
Contact: Mehrdad Golian    6136967000    mgolian@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: David Birnie Ottawa Heart Institute Research Corporation
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Responsible Party: David Birnie, Deputy Chief, Division of Cardiology, University of Ottawa Heart Institute, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04915261    
Other Study ID Numbers: 20210168-01H
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Birnie, Ottawa Heart Institute Research Corporation:
Cardiac
Implantable
Electronic
Device
Arm
Restriction
Post-operative
infection
dislodgement
hematoma
DVT
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes