Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy

Withdrawn

• Conditions: Cardiomyopathy; Heart failure; 10019280

• Registration Number: NL-OMON33558
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A combination of symptomatic improvement (>= 1 class reduction in specific<br /><br>activity scale or >= 25% improvement in 6 minute walk test distance) and LV<br /><br>remodeling (>= 15% decrease of LV end systolic volume or >= 5% increase­ in LV<br /><br>EF).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Rate of late (12-month) response to CRT<br /><br>• Changes in BNP in correlation to cardiac remodeling<br /><br>• Inter- / intra-ventricular dyssynchrony compared to usual optimization</p><br>