Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T (Pre-CRAFT)
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ClinicalTrials.gov Identifier: NCT01930695
: August 29, 2013
Last Update Posted
: January 12, 2015
Biotronik SE & Co. KG
Clinical Trial Unit, University Hospital Basel, Switzerland
The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation
CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)
Permanent atrial fibrillation
Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T
Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)
Patient eligible for programming of DX functionality according to the physicians` decision
Patient is willing and able to comply with the CIP and provided written informed consent
Patient accepts Home Monitoring® concept and has sufficient GSM/GPRS coverage
Patients with any contraindication to CRT-D therapy