NL-OMON41210
Withdrawn
Not Applicable
Patient Status Self-EvaluatioN throuGh Exercise and sonR - PASSENGER
Sorin Group Nederland N.V.0 sites5 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart failure
- Sponsor
- Sorin Group Nederland N.V.
- Enrollment
- 5
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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