Physiologic Pacing Registry

Completed

Conditions studied: Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Ventricular Tachycardia, Heart Failure

In brief

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.

Key facts

Study ID

NCT03719040

Run by

Abbott Medical Devices

People needed

870

Starts

2018-11-27

Expected to finish

2021-10-07

Last updated by the study team

2024-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• University of California at San Diego (UCSD) Medical Center — San Diego, California, United States
• Yoel R. Vivas, MD — Delray Beach, Florida, United States
• Usman R. Siddiqui, MD — Winter Park, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• IU Health Bloomington Hospital — Bloomington, Indiana, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Charlton Memorial Hospital — Fall River, Massachusetts, United States
• Providence Hospital — Southfield, Michigan, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• New York University Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Providence Heart & Vascular Institute — Portland, Oregon, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Pinnacle Health System — Harrisburg, Pennsylvania, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Allegheny General Hospital - ASRI — Pittsburgh, Pennsylvania, United States
• Donald Guthrie Foundation for Education and Research — Sayre, Pennsylvania, United States
• Texas Cardiac Arrhythmia — Austin, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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