NCT03719040

Physiologic Pacing Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 870 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

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.

Conditions

• Bradycardia
• Sinus Node Dysfunction
• Heart Block
• Syncope
• Cardiomyopathies
• Ventricular Tachycardia
• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-27
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2018-10-25
• Last updated: 2024-08-19
• Results posted: 2024-08-19

Locations

50 sites across 16 countries: United States, Australia, Austria, Canada, Czechia, France, Germany, Hong Kong, India, Italy, Netherlands, Poland, Singapore, South Africa, Spain, Switzerland

Regulatory

• FDA-regulated device study