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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03564860
Other study ID # ABT-CIP-10234
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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