SONR-ECHO: Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

Completed

• Conditions: heart failure; heart rhythm disorder; 10019280

• Registration Number: NL-OMON40954
• Lead Sponsor: Sorin Group Nederland N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- indication for a CRT-D implant
- in sinus rhythm
- signed informed consent

Exclusion Criteria

- previous implant of a resynchronisation device
- persistent atrial arrhythmias
- ventricular tachy-arrhythmias secondary to reversible causes
- incessant ventricular tachy-arrhythmias
- unstable angina, acute myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty in the last 4 weeks
- correctable valvular disease as a primary cause for heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Left ventricular end-systolic volume<br /><br>Left ventricular filling time</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A-wave truncation<br /><br>Left ventricular end-diastolic volume<br /><br>Left ventricular ejection fraction<br /><br>Incidence of atrial fibrillation<br /><br>Adverse events</p><br>