Cardiac Failure Heart Failure
Conditions
Interventions
Sponsors
van de Wetering CRC
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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.
Exclusion criteria
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of all system and/or procedure related adverse and serieus adverse events up until 6 months post treatment activation | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of change in the heart function after implant of the device. | — |
Countries
Netherlands
Outcome results
None listed