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
- Conditions
- Cardiac FailureHeart Failure10019280
- Registration Number
- NL-OMON51726
- Lead Sponsor
- van de Wetering CRC
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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
evident.
For HFpEF 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
evident.
* PCW at rest >15 mmHg
* PCW at exercise > 25 mmHg
For BMI corrected NT-proBNP see appendix E
5. Subject should be on stable, maximally-tolerated, guideline-directed
cardiovascular medications for at least 30 days prior to enrolment.
6. Subject has an average heart rate between 60 and 110 b/min recorded in a
24-h Holter measurement.
7. Subject is capable to walk a distance of 150-450 m in 6 minutes hall walk
test.
8. Subject is willing to and capable of providing informed consent.
9. Subject is capable of participating in all tasks associated with this
clinical investigation.
10. Subject can comply with catheterization lab standard of care procedures.
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.
6. Subject has severe Chronic Obstructive Pulmonary Disease (COPD) or severe
restrictive lung disease (e.g., requires chronic steroid use or home oxygen use)
7. Subject has a Body Mass Index (BMI) * 40 kg/m2
8. Subject with renal insufficiency (eGFR<25 ml/min/1.73 m2)
9. Subject has thoracic aorta*s abnormalities or diseases (e.g. aneurysm,
dissection, extensive plaque, implanted stent or stent graft)
10. Subject's thoracic aorta*s anatomy is not compatible with the Harmony*s
implant (e.g. aortic diameter or morphology) based on CT scan analysis.
11. Subject*s thorax anatomy does not enable adequate communication between
implant and the external patient unit based on CT scan analysis.
12. Subject diagnosed with severe valvular (Mitral or Aortic) disease (e.g.
severe stenosis or regurgitation).
13. Subject with prior cardiac transplant or heart transplant candidate.
14. Subject with unstable angina, myocardial infarction, percutaneous
transluminal coronary angioplasty, cerebral vascular accident, transient
ischemic attack or coronary artery bypass graft within 90 days prior to
enrolment.
15. Subject expected to undergo cardiac surgery or percutaneous cardiac
intervention (e.g. coronary and valves) during the study period.
16. Subject whose heart failure is due to congenital heart disease.
17. Subject is unable to take anticoagulants or antiplatelet agents.
18. Subject has infiltrative or restrictive cardiomyopathy.
19. Subject diagnosed with Marfan syndrome.
20. Subject is allergic to iodine or contrast media.
21. Subject has diseases or conditions which, in the judgment of the PI,
preclude participation in the clinical investigation.
22. Subject with a life expectancy of less than 12 months, per PIs' decision.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The occurrence of all system and/or procedure related adverse and serieus<br /><br>adverse events up until 6 months post treatment activation</p><br>
- Secondary Outcome Measures
Name Time Method <p>The assessment of change in the heart function after implant of the device. </p><br>