Physiologic Pacing Registry
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|ClinicalTrials.gov Identifier: NCT03719040|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment|
|Bradycardia Sinus Node Dysfunction Heart Block Syncope Cardiomyopathies Ventricular Tachycardia Heart Failure||Device: Physiologic pacing device implant|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Physiologic Pacing Registry|
|Actual Study Start Date :||November 27, 2018|
|Estimated Primary Completion Date :||November 21, 2021|
|Estimated Study Completion Date :||May 21, 2022|
- Device: Physiologic pacing device implant
An alternative and potentially more effective pacing strategy for patients with electrical conduction abnormalities is physiologic pacing. Physiologic pacing is achieved by delivering a pacing stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch (LBB) of the His-Purkinje system, with a permanent lead. Physiologic pacing activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony. Physiologic pacing has emerged as a feasible and safe alternative to pacemaker therapy and CRT with clinical and electrophysiological advantages.
- Physiologic pacing device implant characteristics [ Time Frame: During procedure ]Data will be collected to characterize the workflow, success, and complications associated with standard-of-care HBP implants in patients indicated for a pacemaker, defibrillator, or CRT device. Data will be compared with and without the use of the EnSite Precision Mapping System used according to each site's routine care.
- Physiologic pacing device implant follow-up characteristics [ Time Frame: 6 Months ]Data will be collected to characterize the workflow, device system electrical performance and programming, and adverse events associated with HBP implants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719040
|Contact: Jemy C Allen||+1 firstname.lastname@example.org|
|Contact: Anuja Kulkarni||+1 email@example.com|
|Study Director:||Clay Cohorn||Abbott|