N/A
N=870
Physiologic Pacing Registry
Bradycardia · Sinus Node Dysfunction · Heart Block · Syncope · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT03719040 ↗Enrolled (actual)
870
Serious AEs
10.9%
Results posted
Aug 2024
Primary outcome: Primary: Physiologic Pacing Implant Success Rate — 768 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Physiologic pacing device implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physiologic Pacing Implant Success Rate |
768 | — |
| PRIMARY Pacing Capture Threshold for His Bundle Pacing |
1.59 | — |
Summary
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
Eligibility Criteria
Inclusion Criteria
- Scheduled for implantation of an Abbott pacemaker, defibrillator, or CRT-P/D device with any commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care.
- At least 18 years of age.
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Provided written informed consent prior to any registry-related procedures.
Exclusion Criteria
- History of tricuspid valve repair or replacement.
- Currently participating in another clinical study with an active treatment arm and belong to the active arm
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results.
- Chronic physiologic pacing lead implanted
- Life expectancy of < 6 months.
- Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).
Data sourced from ClinicalTrials.gov (NCT03719040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.