NL-OMON41210WithdrawnNot Applicable
Patient Status Self-EvaluatioN throuGh Exercise and sonR - PASSENGER
Sorin Group Nederland N.V.0 sites5 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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