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

Primary Purpose

Post-Op Complication

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lenient Arm Restriction
Strict Arm Restriction
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Op Complication focused on measuring Cardiac, Implantable, Electronic, Device, Arm, Restriction, Post-operative, infection, dislodgement, hematoma, DVT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Standalone CIED generator replacement

Sites / Locations

  • University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Strict Arm

Lenient Arm

Arm Description

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: No arm or shoulder movement x 24 hours No movement of affected arm overhead x 8 weeks 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 Avoid any kind of shovelling x 8 weeks

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

Outcomes

Primary Outcome Measures

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
Definitions of each component of primary outcome: Lead dislodgement; dislodgment requiring surgical repair 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 Infection will be categorized into three categories pocket infection, blood stream infection and endocarditis

Secondary Outcome Measures

Rate of hematoma
1. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)
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)
Rate of frozen shoulder
3. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)
Rates of clinically significant pocket infection
5. Rates of clinically significant pocket infection (# of clinically significant device related infections / total number of procedures performed for each arm)

Full Information

First Posted
May 31, 2021
Last Updated
December 8, 2022
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04915261
Brief Title
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
Acronym
LENIENT
Official Title
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication
Keywords
Cardiac, Implantable, Electronic, Device, Arm, Restriction, Post-operative, infection, dislodgement, hematoma, DVT

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strict Arm
Arm Type
Active Comparator
Arm Description
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: No arm or shoulder movement x 24 hours No movement of affected arm overhead x 8 weeks 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 Avoid any kind of shovelling x 8 weeks
Arm Title
Lenient Arm
Arm Type
Active Comparator
Arm Description
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: No shoveling 7 days, No golfing/swimming/tennis 14 days No other restrictions (overhead activity and weight lifting no limitation)
Intervention Type
Behavioral
Intervention Name(s)
Lenient Arm Restriction
Intervention Description
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Intervention Type
Behavioral
Intervention Name(s)
Strict Arm Restriction
Intervention Description
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Primary Outcome Measure Information:
Title
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
Description
Definitions of each component of primary outcome: Lead dislodgement; dislodgment requiring surgical repair 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 Infection will be categorized into three categories pocket infection, blood stream infection and endocarditis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of hematoma
Description
1. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)
Time Frame
1 year
Title
Rate of lead dislodgement
Description
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
Title
Rate of frozen shoulder
Description
3. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)
Time Frame
1 year
Title
Rates of clinically significant pocket infection
Description
5. Rates of clinically significant pocket infection (# of clinically significant device related infections / total number of procedures performed for each arm)
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients undergoing device surgery which includes implantation of at least one new endovascular lead Exclusion Criteria: Standalone CIED generator replacement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Knight
Phone
613.696.7000
Ext
19080
Email
tknight@ottawaheart.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mehrdad Golain
Phone
613.696.7271
Email
mgolain@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Birnie
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Knight
Phone
6136967000
Ext
19080
Email
tknight@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Mehrdad Golian
Phone
6136967000
Email
mgolian@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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