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

Completed

• Conditions: Atrial Fibrillation; Heart Failure

• Registration Number: NCT01930695
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality	3 months	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
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	3 months	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
Quality of IEGM recording	3 months	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
Number of patients with maintenance of diagnosis of permanent AF	3 months	to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation

Trial Locations

Locations (5)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Deutsches Herzzentrum München; 🇩🇪 München, Germany

St. Marien-Hospital Lünen; 🇩🇪 Lünen, Germany

DRK Mölln-Ratzeburg; 🇩🇪 Ratzeburg, Germany

Herz- und Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany