HBP Device EGM Data Collection

Abbott

Status: Completed

Conditions: AV Block; Heart Failure; Sick Sinus Syndrome

Treatments: Procedure: Device data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03564860

ABT-CIP-10234

Details and patient eligibility

About

This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.

Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.

The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has previously implanted with Abbott device and any pacing lead at HB
• Age ≥ 18 years
• Ability to provide informed consent for study participation
• Willing to comply with study evaluation requirements

Exclusion criteria

• Suspected pacing system failure
• Lead impedance out of range
• Ventricular sensing amplitude lower than 0.5 mV

Trial design

200 participants in 1 patient group

HBP device data collection group

Description:

Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit.

Treatment:

Procedure: Device data collection