Lenient Arm for Postoperative Complications

Phase-Based Progress Estimates
University of Ottawa Heart Institute, Ottawa, CanadaPostoperative ComplicationsStrict Arm Restriction - Behavioral
Any Age
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Postoperative Complications

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 1 year

1 year
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
Rate of frozen shoulder
Rate of hematoma
Rate of lead dislodgement
Rates of clinically significant pocket infection

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Lenient Arm
1 of 2
Strict Arm
1 of 2

Active Control

2500 Total Participants · 2 Treatment Groups

Primary Treatment: Lenient Arm · No Placebo Group · Phase 4

Lenient Arm
ActiveComparator Group · 1 Intervention: Lenient Arm Restriction · Intervention Types: Behavioral
Strict Arm
ActiveComparator Group · 1 Intervention: Strict Arm Restriction · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
179 Previous Clinical Trials
85,044 Total Patients Enrolled
David BirniePrincipal InvestigatorOttawa Heart Institute Research Corporation
2 Previous Clinical Trials
1,172 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.