A Frequent Optimization Study Using the QuickOpt Method

Phase 4

Withdrawn

• Conditions: 10019280; Heart Failure

• Registration Number: NL-OMON30958
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- patient meets current CRT-D indications and be impanted with an SJM CRT-D device with V-V timing and a compatible lead system
- patient had the ability to complete a 6-minute hall walk with the only limiting factor to be fatique of shortness of breath.
- patient older than 18 year.

Exclusion Criteria

- patient is less than 18 years old.
- patient has persistent of permanent AF.
- patient has the ability to walk > 450 meters in 6 minutes.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this clinical investigation is to demonstrate that the<br /><br>proportion of improved patients in the treatment group is superior to the<br /><br>proportion in the control group, 12 months post-implantation.<br /><br>The Heart Failure Clinical Composite Response22 will be used to evaluate the<br /><br>status of the patient.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of the study are:<br /><br>* All-cause, cardiovascular and heart failure mortality;<br /><br>* All-cause, cardiovascular and heart failure hospitalizations.</p><br>