Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

Completed

• Conditions: Ventricular Arrhythmias; Heart Failure
• Interventions: Device: CRT device implant

• Registration Number: NCT00996086
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2010-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Meets current clinical indications for CRT-D therapy
• Patient is 18 years old or older
• Ability to independently comprehend and complete all QOL questionnaires
• Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
• Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria

• Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
• Myocardial infarction in the last 3 weeks
• Unstable angina in the last 3 weeks
• Status 1 classification for cardiac transplantation
• Currently participating in a clinical trial that includes an active treatment arm
• Life expectancy of less than 12 months.
• Recent (within 1 week) administration of Nesiritide™ or inotropes
• Patients in whom revascularization is expected
• Patient is pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT device-recipients	CRT device implant	-

Primary Outcome Measures

Name	Time	Method
Change in 6-minute hall walk distance between baseline and subsequent follow-up	12 months
Composite endpoint a. 6-minute hall walk distance b. NYHA Classification c. Quality of Life (Minnesota Living with Heart Failure, DASS, SF-36)	12 months
The occurrence of either death (all-cause) or first HF hospitalization.	12 months

Secondary Outcome Measures

Name	Time	Method
Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index	12 months
Quality of Life	12 months
Cause-specific mortality	12 months

Trial Locations

Locations (2)

Veterans' Adminstration Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States

Touro College; 🇺🇸 New York, New York, United States