Monitoring of hemodynamics in heart failure patients by intracardiac impedance measurement - Bio.Detect HFII

Biotronik0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

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•* 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%
•* LVEDD >= 55mm
•* QRS >= 150ms

•* 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.
•* Limited contractual capability.
•* Pregnant or breast-feeding women.
•* Participation in another clinical trial.

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