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Physiologic Pacing Registry

Sponsored by Abbott Medical Devices

About this trial

Last updated 3 years ago

Study ID

ABT-CIP-10270

Status

Completed

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

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.

No

Exclusion Criteria

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.).