NL-OMON39966
Recruiting
Not Applicable
Monitoring of hemodynamics in heart failure patients by intracardiac impedance measurement - Bio.Detect HFII
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biotronik
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients with an indication for CRT\-D device implantation according to the opinion of the treating physician who were not implanted with a CRT\-device before (de novo CRT\-patients only).
- •\* Patients being implanted with single and dual chamber ICDs before may be included in the study.
- •\* Patients who are planned to be implanted with a BIOTRONIK Lumax740 HF\-T device (or successor).
- •\* Patients planned to be implanted with a bipolar LV\-lead with a minimum distance of 15 mm between tip and ring.
- •\* Patients implanted (or planned to be implanted) with a true bipolar RV\-lead.
- •\* Patients with NYHA class II and III (with both ischemic or non\-ischemic etiology or dilative cardiomyopathy as underlying disease)
- •\* Patient is willing and able to comply with the CIP and has provided written informed consent.
- •\* Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage.
- •\* Evaluable echocardiographic measurements.
- •\* Patients with LVEF \>\= 15% and \<\= 35%
Exclusion Criteria
- •\* Patients with diagnosed persistent or permanent atrial fibrillation.
- •\* Patients suffering from aortic valve stenosis or from more than a trace of aortic valve insufficiency patients with aortic valve prosthesis.
- •\* Heart surgery performed in the 3 months prior to enrollment or planned for the time of study participation.
- •\* PTCA expected within the first 3 months of study participation.
- •\* Post\-HTX or listed for HTX.
- •\* Non\-ambulatory patients.
- •\* Patients requiring chronic renal dialysis.
- •\* Life expectancy \< 1 year due to a noncardiac disease.
- •\* Patient age \< 18 years.
- •\* Patient is addicted to alcohol, medical drugs or illegal drugs.
Outcomes
Primary Outcomes
Not specified
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