Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Details

The Physiologic Pacing Registry will be conducted to gain a deeper understanding of physiologic pacing device implants and follow-up workflows, including device and programmer measurements to help inform Abbott's product and clinical data development efforts. Additionally, the registry will provide a broader understanding of the clinical utility in mapping physiologic pacing structures with the use of Abbott's EnSite Cardiac Mapping System with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to physiologic pacing device implant. The registry will include patients undergoing implantation of an Abbott pacemaker, defibrillator, or a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D) according to the clinical site's routine care. Only patients scheduled to receive an Abbott device may be enrolled to ensure proper device data collection for future software and other physiologic pacing product development. The decision to provide physiologic pacing therapy and selection of devices for implant are at the discretion of the implanting physician. Abbott will collect data on the use of all commercially available leads and associated implant tools based on the physician's discretion as part of routine clinical practice within the registry.

Keywords

Bradycardia Sinus Node Dysfunction Heart Block Syncope Cardiomyopathies Ventricular Tachycardia Heart Failure Tachycardia Tachycardia, Ventricular Sick Sinus Syndrome Physiologic pacing device implant

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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.
  2. At least 18 years of age.
  3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  4. Provided written informed consent prior to any registry-related procedures.

You CAN'T join if...

  1. History of tricuspid valve repair or replacement.
  2. Currently participating in another clinical study with an active treatment arm and belong to the active arm
  3. 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.
  4. Chronic physiologic pacing lead implanted
  5. Life expectancy of < 6 months.
  6. Known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).

Locations

  • University of California at San Diego (UCSD) Medical Center in progress, not accepting new patients
    San Diego California 92103 United States
  • Mills-Peninsula Medical Center in progress, not accepting new patients
    Burlingame California 94010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT03719040
Study Type
Observational [Patient Registry]
Last Updated