Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy.
OPTIMISE-CRT
1 other identifier
interventional
461
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 heart-failure
Started Jun 2007
Longer than P75 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 18, 2015
November 1, 2015
5.4 years
June 20, 2007
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical benefit (reduction in SAS of at least 1 class or a 25% or larger improvement in 6 minute hall walk distance) plus structural remodeling (15% or greater reduction in left LV end systolic volume or ≥ 5% absolute improvement in echo-derived LV EF)
12 months
Secondary Outcomes (3)
Rate of late (12-month) versus early (3 month) response to CRT
3 and 12 months
Changes in BNP
3 and 12 months
Inter-/intra-ventricular dysynchrony
3 and 12 months
Study Arms (2)
A
ACTIVE COMPARATORQuickOpt
B
PLACEBO COMPARATORUsual care
Interventions
Eligibility Criteria
You may qualify if:
- CRT-D indications and be implanted with an SJM CRT-D device with VV timing and a compatible lead system.
- Able to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Geographically stable and willing to comply with follow-up.
- Adequate echocardiographic images to measure LV end systolic volume.
You may not qualify if:
- Epicardial ventricular lead system.
- Ability to walk ≥ 450 meters in 6 minutes
- Limited intrinsic atrial activity (≤ 40 bpm).
- Persistent or permanent AF.
- ° or 3° heart block.
- Life expectancy is less than 1 year.
- Patient is pregnant.
- Receiving IV inotropic agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Abbott Medical Devicescollaborator
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Derek V Exner, MD, MPH
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
June 1, 2007
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 18, 2015
Record last verified: 2015-11