CompletedNot Applicable

Physiologic Pacing Registry

United States870 participantsStarted 2018-11-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.).

What they're measuring

Physiologic Pacing Implant Success Rate

Timeframe: During procedure

Pacing Capture Threshold for His Bundle Pacing

Timeframe: 6 Months

Trial details

NCT IDNCT03719040

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-10-07

Results submitted2023-04-25

View on ClinicalTrials.gov More Bradycardia trials