Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy.
NCT00489177 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 461
Last updated 2015-11-18
Summary
This international study is assessing if repeat adjustment of the timing between the three leads in a cardiac resynchronization therapy (CRT) defibrillator will increase the likelihood of benefit (symptoms and heart function) compared to usual device programming. The hypothesis is that QuickOpt facilitated serial optimization of sensed atrioventricular (sAV), paced atrioventricular (pAV), and inter-ventricular (VV) timing in the initial 9 months following successful CRT will increase the rate of clinical response and structural remodeling at 12 months compared to usual care.
Conditions
Interventions
- DEVICE
-
A
QuickOpt intra-cardiac electrogram optimization
- DEVICE
-
B
Single optimization in initial month post-implant
Sponsors & Collaborators
-
Abbott Medical Devices
collaborator INDUSTRY -
University of Calgary
lead OTHER
Principal Investigators
-
Derek V Exner, MD, MPH · University of Calgary
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Canada
Study Locations
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