Bradycardia Clinical Trial
— RADICAL USEOfficial title:
Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound (RADICAl USe)
NCT number | NCT04858698 |
Other study ID # | 10510 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2021 |
Est. completion date | December 31, 2024 |
Verified date | February 2024 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Specialized equipment is required to put pacemakers in the heart. This requires use of radiation to see the wires or leads being implanted in the heart. Repeated radiation use can result in permanent injury to the patient and to the doctor. The investigators aim to investigate if they can use ultrasound to guide and help in the implantation of leads into the heart. Ultrasound is a safe method and requires only a small handheld probe and a small screen to see different structures in the heart. If ultrasounds proves successful as a tool to reduce radiation then this would be very useful technical breakthrough. It would help develop smaller centres where pacemakers can be implanted without purchasing xray equipment and expensive setups.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age >18 years old. 2. Suitable to have either a single chamber pacemaker or single chamber cardioverter-defibrillator. Exclusion Criteria: 1. BMI >30. 2. Pregnancy. 3. Implantation of dual-chamber and CRT devices. 4. Claustrophobia. 5. Tender chest wall or history of trauma to the chest wall. 6. Higher signal interference using ultrasound due to the presence of other medical devices or tools used in previous surgical procedures such as sternal wires, mechanical valves, breast implants. 7. History of radiation to the chest wall for oncology treatments. 8. Active malignancy |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre Res. Inc. (Ont.) | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Habib Khan |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of implanting a single chamber lead with use of ultrasound | Binary outcome - successful or not. | 0 day | |
Secondary | Duration of radiation will be measured in seconds | Comparison between the treatment and control group | during procedure | |
Secondary | Total radiation dose will be collected in centiGray and milliGray units. | Comparison between the treatment and control group | during procedure |
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