← Back to Search

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

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery to implant a new device in my blood vessels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Rate of frozen shoulder

Rate of hematoma

Rate of lead dislodgement

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: 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

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: 1. No shoveling 7 days, 2. No golfing/swimming/tennis 14 days 3. No other restrictions (overhead activity and weight lifting no limitation)

0 / 1Eligibility criteria met