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NCT03564860 · ClinicalTrials.gov registry record
HBP Device EGM Data Collection
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 200
- Enrollment target
NCT03564860: Completed study, sponsored by Abbott Medical Devices.
NCT03564860 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03564860 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
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.
Primary Outcome
Mean amplitude of device electrogram during His bundle pacing
Interventions
- PROCEDURE Device data collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2020-09-30 |
What the finished NCT03564860 record still lists
NCT03564860 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Device data collection is the first listed.
NCT03564860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03564860 about?
NCT03564860 is a clinical study titled "HBP Device EGM Data Collection". 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 electrocardiogra...
What is the current status of trial NCT03564860?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2018-07-17. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT03564860?
The interventions under investigation include: Device data collection (PROCEDURE).
Who is sponsoring clinical trial NCT03564860?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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