Post-Op ComplicationPhase 4LENIENTNCT04915261
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
A Phase 4 study testing Lenient Arm Restriction and Strict Arm Restriction in people with Post-Op Complication, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- Lenient Arm Restriction and Strict Arm Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,300 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2021to 1 Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients undergoing device surgery which includes implantation of at least one new endovascular lead
Who cannot join
- Standalone CIED generator replacement
- Subcutaneous implantable cardioverter defibrillators
- Leadless endocardial pacemakers
- Temporary permanent pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Tammy Knight, 6136967000 ext. 19080, tknight@ottawaheart.ca
Mehrdad Golian, 6136967000, mgolian@ottawaheart.ca
About this study
Official title: A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
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.
Read more
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.
Read the 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.
- Conditions
- Post-Op Complication
- Being tested
- Lenient Arm Restriction, Strict Arm Restriction
- Keywords
- Cardiac, Implantable, Electronic, Device, Arm, Restriction, Post-operative, infection, dislodgement, hematoma, DVT
- Medical subject headings
- Postoperative Complications, Infections, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenient Arm RestrictionBehavioural
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Strict Arm RestrictionBehavioural
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Strict Arm | Active comparator | 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 Receives: Behavioral: Strict Arm Restriction |
| Lenient Arm | Active comparator | 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) Receives: Behavioral: Lenient Arm Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 1 year
Secondary outcomes (3)
Rate of hematoma
- Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)
Measured: 1 year
Rate of lead dislodgement
- 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)
Measured: 1 year
Rate of frozen shoulder
- Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start19 Aug 2021
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Birnie, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915261
- Sponsor's protocol ID
- 20210168-01H
- Acronym
- LENIENT
- Status last verified
- Jul 2026
- First submitted
- 31 May 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Golian M, Sadek MM, Aydin A, Davis D, Green M, Klein A, Nair GM, Nery P, Ramirez FD, Redpath C, Hansom SP, Wells GA, Birnie DH. A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT). Am Heart J. 2023 May;259:52-57. doi: 10.1016/j.ahj.2023.01.016. Epub 2023 Jan 25.
PubMed 36708911
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
- ClinicalTrials.gov ID
- NCT04915261
- Acronym / sponsor ID
- LENIENT / 20210168-01H
- Conditions
- Post-Op Complication
- Keywords
- Cardiac, Implantable, Electronic, Device, Arm, Restriction, Post-operative, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Strict Arm | Active comparator | Behavioral: Strict Arm RestrictionThe 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 |
| Lenient Arm | Active comparator | Behavioral: Lenient Arm RestrictionThe 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing device surgery which includes implantation of at least one new endovascular lead
Key exclusion criteria (4 listed)
- Standalone CIED generator replacement
- Subcutaneous implantable cardioverter defibrillators
- Leadless endocardial pacemakers
- Temporary permanent pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenient Arm RestrictionThe study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions. | Behavioural | Lenient Arm |
| Strict Arm RestrictionThe study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions. | Behavioural | Strict Arm |
Primary outcome
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: 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.
3 secondary outcomes
Rate of hematoma
Time frame: 1 year
Rate of lead dislodgement
Time frame: 1 year
Rate of frozen shoulder
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 36708911Golian M, Sadek MM, Aydin A, Davis D, Green M, Klein A, Nair GM, Nery P, Ramirez FD, Redpath C, Hansom SP, Wells GA, Birnie DH. A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT). Am Heart J. 2023 May;259:52-57. doi: 10.1016/j.ahj.2023.01.016. Epub 2023 Jan 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Birnie principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lenient Arm Restriction and Strict Arm Restriction in people with Post-Op Complication, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tammy Knight (613.696.7000 ext. 19080, tknight@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04915261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.