NCT01805154

Advance Cardiac Resynchronization Therapy (CRT) Registry

Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,529 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.

Detailed description

Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all patients will be followed at every 3 months for the first 12 months from the implant. The responder/non-responder evaluation will occur at 6 months from the implant date. The criteria used for determining the response to CRT will be captured. During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT Patients	This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-11-01
• Completion: 2017-09-01
• First posted: 2013-03-06
• Last updated: 2019-08-12
• Results posted: 2019-08-12

Locations

69 sites across 9 countries: United States, Argentina, Brazil, China, Colombia, India, Japan, Puerto Rico, South Korea