Recruiting

Ultrasound Guidance

Sponsor:

Habib Khan

Code:

NCT04858698

Conditions

Bradycardia

Brady-tachy Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound / Echocardiography

Study Details

Brief 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.

Conditions

Bradycardia

Brady-tachy Syndrome

Study ID

NCT04858698

Start date

Jul 30, 2021

Status verified date

Feb, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reduced fluoroscopy arm

Patients exposed to 20 seconds or less of fluoroscopy to implant a single chamber device with aid of ultrasound / echocardiography.

active comparator: Conventional arm

Patients exposed to more than 20 seconds of fluoroscopy to implant a single chamber device with/without the aid of ultrasound / echocardiography.

Interventions

Ultrasound / Echocardiography

Ultrasound will be used to guide vascular access and to place a lead into the right ventricle.

Primary outcome measure

  • Success of implanting a single chamber lead with use of ultrasound [ Time Frame: 0 day ]

Central Contacts and Locations

Locations

London Health Sciences Centre Res. Inc. (Ont.)

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Habib I Khan

5196633135habib.khan@lhsc.on.ca

More Information

Sponsor

Habib Khan

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Habib Khan on 2024-02-21.