Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04915261
Other study ID # 20210168-01H
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 19, 2021
Est. completion date June 1, 2025

Study information

Verified date May 2024
Source Ottawa Heart Institute Research Corporation
Contact Tammy Knight
Phone 613.696.7000
Email tknight@ottawaheart.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 7 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 our device clinic and 24/7 on call nursing program.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients undergoing device surgery which includes implantation of at least one new endovascular lead Exclusion Criteria: - Standalone CIED generator replacement

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Lenient Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Strict Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Locations

Country Name City State
Canada University of Ottawa Heart Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Definitions of each component of primary outcome:
Lead dislodgement; dislodgment requiring surgical repair
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
Infection will be categorized into three categories pocket infection, blood stream infection and endocarditis
1 year
Secondary Rate of hematoma 1. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm) 1 year
Secondary Rate of lead dislodgement 2. 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) 1 year
Secondary Rate of frozen shoulder 3. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm) 1 year
Secondary Rates of clinically significant pocket infection 5. Rates of clinically significant pocket infection (# of clinically significant device related infections / total number of procedures performed for each arm) 1 year
See also
  Status Clinical Trial Phase
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Recruiting NCT04084938 - Artery Embolization vs Operation of Benign Prostate Hyperplasia N/A
Enrolling by invitation NCT03922737 - Telehealth Following Orthopaedic Procedures N/A
Not yet recruiting NCT05248139 - Safety and Effectiveness of Drop-free Small Incision Cataract Surgery N/A
Completed NCT05596552 - Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries Phase 4
Not yet recruiting NCT04509986 - GlobalSurg-CovidSurg Week
Completed NCT04082598 - Antibiotic Therapy in Erupted Tooth Extractions Phase 4
Completed NCT04168307 - Physiotherapy Versus Use of a New Ankle Trainer Device After Ankle Fracture Operation. N/A
Recruiting NCT02980770 - Postoperative Complications in Patients With Obesity Hypoventilation Syndrome N/A
Recruiting NCT03323619 - Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
Completed NCT04268576 - Impact of an Improved Rehabilitation Program After a Scheduled Hysterectomy.
Completed NCT04620850 - Effect of Acupressure on Recovery of Bowel Function in Patients Post Cesarean Section N/A
Completed NCT05592145 - Quantifying the Venous Congestion Curve of a Tissue Oximetry Device N/A
Completed NCT03192917 - Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy N/A
Completed NCT03036072 - Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery N/A
Completed NCT03230474 - a Small Dose of Naloxone,Minimize Intrathecal Morphine Side Effects N/A
Recruiting NCT05269368 - Interest of Wicking for Ossicular Surgery and Myringoplasty N/A
Completed NCT04301232 - Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
Completed NCT04700995 - Postoperative Pain After Using NiTi Instruments N/A
Recruiting NCT06050551 - Pigtail or Chest Tube Placement After Uniportal Video-assisted Thoracoscopic Surgery N/A