Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

Abbott Medical Devices154 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

154

Conditions

Heart Failure Ventricular Arrhythmias

Interventions

CRT device implantDEVICE

CRT device-recipients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Touro College

New York, New York, United States

Veterans' Adminstration Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in 6-minute hall walk distance between baseline and subsequent follow-up

Time frame: 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)

Time frame: 12 months

The occurrence of either death (all-cause) or first HF hospitalization.

Time frame: 12 months

Secondary Outcomes

Quality of Life

Time frame: 12 months

Change in echocardiographic variables including: a. Ejection Fraction b. Wall motion score c. Increase in TD velocity d. Yu index

Time frame: 12 months

Cause-specific mortality

Time frame: 12 months

Data from ClinicalTrials.gov

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