To demonstrate that QuickOptTM facilitated optimization of AV and VV timing in the initial 9 months following successful CRT-D will increase the rate of clinical response and structural remodeling at 12 months compared to usual care.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A combination of symptomatic improvement (>= 1 class reduction in specific
activity scale or >= 25% improvement in 6 minute walk test distance) and LV
remodeling (>= 15% decrease of LV end systolic volume or >= 5% increase in LV
EF).
Secondary outcome
• Rate of late (12-month) response to CRT
• Changes in BNP in correlation to cardiac remodeling
• Inter- / intra-ventricular dyssynchrony compared to usual optimization
Background summary
Cardiac resynchronization therapy (CRT) is primarily designed to synchronize
the mechanical activity of the heart. While CRT is beneficial in average, a
sizable proportion of patients do not clearly benefit from (respond to) CRT.
Whether routinely optimizing the timing between the atria and ventricles (AV
timing) and the timing between the left and right ventricles (VV timing) will
significantly increase the likelihood of patients benefiting from (responding
to) CRT is unknown.
Study objective
To demonstrate that QuickOptTM facilitated optimization of AV and VV timing in
the initial 9 months following successful CRT-D will increase the rate of
clinical response and structural remodeling at 12 months compared to usual
care.
Study design
This post market study is a double-blind, randomized, prospective, multicenter,
parallel design with a control group.
Intervention
Group 1 has optimalization of A-V and V-V delays using Quickopt at 3, 6, 9 and
12 months after implantation.
Group 2 has a one time only optimalization of the A-V and V-V delays according
to the standard hospital protocol within 4 weeks after implantation.
Study burden and risks
The risks involved with this study are similar to those associated with
implantation and follow-up of other commercially available CRT-D system. There
should be no additional risks to the patients assigned to the study.
Drawing blood for BNP at baseline, 3 and 12 months will give a small risk on
bruises.
The burden is mainly a time burden of around 6 hours for the whole study.
Standaardruiter 13
3905 PT Veenendaal
Nederland
Standaardruiter 13
3905 PT Veenendaal
Nederland
Listed location countries
Age
Inclusion criteria
• Patient meets current CRT-D indications and be implanted with an SJM CRT-D device with V-V timing and a compatible lead system.
• Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
• Patient is geographically stable and willing to comply with the required follow-up schedule.
• Adequate echocardiographic images to measure LV end systolic volume
Exclusion criteria
• Patient has an epicardial ventricular lead system.
• Patient has the ability to walk >= 450 meters in 6 minutes
• Patient has limited intrinsic atrial activity (<= 40 bpm).
• Patient has persistent or permanent AF.
• Patient has a 2° or 3° heart block.
• Patient*s life expectancy is less than 1 year
• Patient is less than 18 years old.
• Patient is pregnant.
• Patient is on IV inotropic agents.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25730.091.09 |