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HBP Device EGM Data Collection

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Sick Sinus Syndrome
  • Atrioventricular Heart Block
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amplitude of device electrogram
Duration of device electrogram

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HBP device data collection groupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Device data collection
2018
N/A
~200

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
652 Previous Clinical Trials
416,637 Total Patients Enrolled
8 Trials studying Sick Sinus Syndrome
1,934 Patients Enrolled for Sick Sinus Syndrome
~27 spots leftby Jan 2026
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