NCT00996086

Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

Risk Stratification and Benefits With Cardiac Resynchronization Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

Detailed description

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated. This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Conditions

• Heart Failure
• Ventricular Arrhythmias

Interventions

Type	Name	Description
DEVICE	CRT device implant	CRT device-recipients

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-10-16
• Last updated: 2019-02-04

Locations

2 sites across 1 country: United States