Physiologic Pacing Registry

Heart Failure Clinical Trial

Official title: Physiologic Pacing Registry

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03719040
• Study type: Observational [Patient Registry]
• Source: Abbott Medical Devices
• Status: Completed
• Start date: November 27, 2018
• Completion date: October 7, 2021