HBP Device EGM Data Collection

NCT ID: NCT03564860

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-17

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sick Sinus Syndrome AV Block Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HBP device data collection group

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.

Device data collection

Intervention Type PROCEDURE

Collection of device electrograms and 12-lead ECG during a device follow-up visit

Interventions

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Device data collection

Collection of device electrograms and 12-lead ECG during a device follow-up visit

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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*Heart Center Research, LLC.

Huntsville, Alabama, United States

Site Status

Donald Guthrie Foundation for Education & Research

Sayre, Pennsylvania, United States

Site Status

Greenville Health System

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ABT-CIP-10234

Identifier Type: -

Identifier Source: org_study_id

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