MedTrace Logo

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

NCT00418314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1647

Last updated 2019-02-19

Study results available
· View outcomes & findings →

Summary

The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).

Conditions

Interventions

DEVICE

Control

Empiric programming or one-time optimization using a non-IEGM method.

DEVICE

QuickOpt

Frequent optimization using QuickOpt to optimize AV/PV and VV delays.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • William Abraham, MD · Ohio State University, Columbus, OH, USA

  • Daniel Gras, MD · Nouvelles Cliniques Nantaises, Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

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 NCT00418314 on ClinicalTrials.gov