HBP Device EGM Data Collection

Heart Failure Clinical Trial

Official title:

His Bundle Pacing Device Electrogram Data Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564860
• Other study ID #: ABT-CIP-10234
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AV Block
• Heart Failure
• Sick Sinus Syndrome

Intervention

Procedure:
• Device data collection
Collection of device electrograms and 12-lead ECG during a device follow-up visit

Locations

Country	Name	City	State
United States	Greenville Health System	Greenville	South Carolina
United States	*Heart Center Research, LLC.	Huntsville	Alabama
United States	Donald Guthrie Foundation for Education & Research	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of device electrogram	Mean amplitude of device electrogram during His bundle pacing	through study completion, an average of 1 year
Primary	Duration of device electrogram	Mean duration of device electrogram during His bundle pacing	through study completion, an average of 1 year