UnknownNot Applicable

Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound

Canada66 participantsStarted 2021-07-30

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \>18 years old.
✓. Suitable to have either a single chamber pacemaker or single chamber cardioverter-defibrillator.

Exclusion criteria

✕. BMI \>30.
✕. Pregnancy.
✕. Implantation of dual-chamber and CRT devices.
✕. Claustrophobia.
✕. Tender chest wall or history of trauma to the chest wall.
✕. 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.
✕. History of radiation to the chest wall for oncology treatments.
✕. Active malignancy

What they're measuring

Success of implanting a single chamber lead with use of ultrasound

Timeframe: 0 day

Trial details

NCT IDNCT04858698

SponsorHabib Khan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Bradycardia trials