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Arm Restriction Strategies After Cardiac Device Surgery (LENIENT Trial)
Phase 4
Recruiting
Led By David Birnie
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients undergoing device surgery which includes implantation of at least one new endovascular lead
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
LENIENT Trial Summary
This trial is designed to compare two different types of arm restrictions for people with CIEDs, in order to improve patient experience and reduce complications.
Who is the study for?
This trial is for patients who have just had surgery to receive a Cardiac Implantable Electronic Device (CIED) and are facing postoperative recovery. It's open to those getting at least one new endovascular lead but not for patients only having their CIED generator replaced.Check my eligibility
What is being tested?
The study compares two types of arm movement restrictions after CIED surgery: 'lenient' allows more freedom, while 'strict' limits arm use significantly. The goal is to see which leads to better patient experiences and fewer complications.See study design
What are the potential side effects?
Since this trial involves following different instructions rather than taking medications, there aren't typical side effects. However, strict restrictions might cause discomfort or inconvenience, affecting the patient's quality of life.
LENIENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to implant a new device in my blood vessels.
LENIENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Secondary outcome measures
Rate of frozen shoulder
Rate of hematoma
Rate of lead dislodgement
+1 moreLENIENT Trial Design
2Treatment groups
Active Control
Group I: Strict ArmActive Control1 Intervention
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
Group II: Lenient ArmActive Control1 Intervention
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)
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
89,936 Total Patients Enrolled
David BirniePrincipal InvestigatorOttawa Heart Institute Research Corporation
2 Previous Clinical Trials
1,172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery to implant a new device in my blood vessels.
Research Study Groups:
This trial has the following groups:- Group 1: Strict Arm
- Group 2: Lenient Arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Strict Arm attained the necessary certifications from the Federal Drug Administration?
"Given that this is a Phase 4 trial, which indicates full approval of the treatment, Strict Arm's safety was rated as a 3 on our 1 to 3 scale."
Answered by AI
How many participants are enrolled in this trial?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial opened for recruitment on August 19th 2021 and is still looking for participants. 2500 people are needed from a single location to take part in the study."
Answered by AI
Is there still room for participation in this clinical investigation?
"Clinicaltrials.gov indicates that this clinical trial is currently open for patient recruitment, with the original posting date being August 19th 2021, and last revision made on September 6th of the same year."
Answered by AI
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