Patient Status Self-EvaluatioN throuGh Exercise and sonR

Withdrawn

• Conditions: Heart failure; 10019280; heart rhythm disorder

• Registration Number: NL-OMON41210
• 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• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- patients implanted with a CRT-D device according to published relevant ESC guidelines in the last 5 days;
- patients implanted with an Implantable cardioverter defibrillator (CRT-D) device equipped with SonR technology;
- patients implanted with a SonRtip tm right atrial lead;
- patients in sinus rhythm;
- patients on stable medical therapies regimen;
- patients capable to perform stress test;
- patients reviewed, sign and dated an informed consent form

Exclusion Criteria

patients with:
- persistent atrial arrhythmias within the past three months;
- unstable angina or acure MI within the past 3 months;
- already included in another clinical study that could confound the results of this study
- pregnancy;
- vulnerable subjects as defined in ISO 14155:2011;
- unavailability for scheduled follow-up or refusal to cooperate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is to investigate any relationship between<br /><br>changes in the SonR1 augmentation and a change in the exercise capacity of CRT<br /><br>patients as assessed by the 6MWTbetween follow-ups</p><br>