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HBP Device EGM Data Collection

NCT03564860 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Device data collection

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564860 on ClinicalTrials.gov