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Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

NCT00187200 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2019-02-05

Study results available
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Summary

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

* \< 10% improvement in 6-minute hall walk, and
* no class improvement or worsening in New York Heart Association (NYHA) scale.

For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

* \> 1 heart failure (HF) related hospitalization, and
* no class improvement or worsening in NYHA scale.

Conditions

Interventions

DEVICE

Simultaneous VV Pacing

Right ventricular and left ventricular pacing delivered simultaneously.

DEVICE

Sequential VV Pacing

Right ventricular and left ventricular pacing delivered sequentially.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Raul Weiss, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

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 NCT00187200 on ClinicalTrials.gov