MedTrace Logo

Physiologic Pacing Registry

NCT03719040 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 870

Last updated 2024-08-19

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kwangdeok Lee · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2021-10-07
Completion
2021-10-07
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Netherlands
  • Poland
  • Singapore
  • South Africa
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719040 on ClinicalTrials.gov