NL-OMON51726
Completed
N/A
A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart Failure - ENDO-HF
van de Wetering CRC0 sites2 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Failure
- Sponsor
- van de Wetering CRC
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is at least 18 years old but no more than 85 years old
- •2\. Subject is a male or a postmenopausal female, or a female of childbearing
- •age for whom pregnancy was excluded and who has accepted to use adequate
- •contraception measures for the entire study duration
- •3\. Subject is diagnosed as chronic heart failure NYHA class II\-III.
- •4\. Heart Failure is accompanied by:
- •For HFrEF Subjects (must meet at least one of the following):
- •\* BMI\-corrected NT\-proBNP\> 300pg/ml.
- •\* BMI\-corrected NT\-proBNP\*450 pg/ml if persistent atrial fibrillation is
- •For HFpEF subjects (must meet at least one of the following):
Exclusion Criteria
- •1\. Subject has a Cardiac Resynchronization Therapy (CRT) or is a candidate
- •within the next 6 months to have one
- •2\. The subject has a permanent pacemaker and is 100% pacemaker dependent.
- •3\. Subject has an Implantable Cardioverter Defibrillator (ICD) and/or any other
- •active electrical implant that is found to be affected by the Harmony System
- •operation in a compatibility assessment performance.
- •4\. Subject has significant uncontrolled symptomatic bradyarrhythmias or
- •unstable ventricular arrhythmias.
- •5\. Subject has a 1st degree AV block with PR interval \> 240msec, 2nd or 3rd
- •degree AV block.
Outcomes
Primary Outcomes
Not specified
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