Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

Study Overview
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Brief Summary
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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.

Official Title
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Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

Conditions
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Atrial Fibrillation, Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with any contraindication to CRT-D therapy Patients listed for heart transplantation Life expectancy less than 12 months Pregnant or breast-feeding women Patients under the age of 18 Patients with limited contractual capability Participation in any other clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of IEGM recording | to assess if the IEGM Online recordings of the Lumax 640/740 HF-T with DX functionality provide adequate quality to classify the atrial rhythm | 3 months | 
| Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality | to assess the safety of the Lumax 640/740 HF-T by the analysis of Serious Adverse Device Effects which are related to the DX functionality | 3 months | 
| Safety of the Lumax 640/740 HF-T with DX functionality based on all, serious and non-serious, Adverse Device Effects related to DX functionality | to assess the safety of the Lumax 640/740 HF-T with DX functionality by the analysis of all (serious and non-serious) Adverse Device Effects which are related to the DX functionality | 3 months | 
| Number of patients with maintenance of diagnosis of permanent AF | to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DX functionality, Atrial fibrillation, CRT-D indication