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Search / Trial NCT04915261

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

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · May 31, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cardiac Implantable Electronic Device Arm Restriction Post Operative Infection Dislodgement Hematoma Dvt

ClinConnect Summary

This clinical trial is looking at how different types of arm restrictions following cardiac device surgery can affect patients' recovery and overall experience. Specifically, the study compares "lenient" instructions, which allow more movement of the arm, to "strict" instructions, which limit arm movement. The goal is to find out if relaxing these restrictions can help patients feel better and reduce the chance of complications after surgery, since many patients receive mixed advice about what they can and cannot do after their procedure.

Anyone who is having surgery to implant a cardiac device that includes at least one new lead may be eligible to participate in this study. Throughout the trial, patients will receive clear instructions about their arm restrictions through both printed materials and phone reminders. The study will also ensure that all patients are monitored for any follow-up care or complications. This research is important because it aims to make the recovery process easier and less stressful for patients after they receive their cardiac devices.

Gender

ALL

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

About Ottawa Heart Institute Research Corporation

The Ottawa Heart Institute Research Corporation is a leading clinical research organization dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Affiliated with the renowned University of Ottawa Heart Institute, the corporation focuses on conducting high-quality, ethically-driven studies that aim to improve patient outcomes and enhance understanding of heart-related diseases. With a commitment to collaboration and excellence, the organization engages multidisciplinary teams of researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective therapies and interventions for cardiovascular health.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

David Birnie

Principal Investigator

Ottawa Heart Institute Research Corporation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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