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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Gefäßzentrum Bad Bevensen, Bad Bevensen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Quality of IEGM recording

Time frame: 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
Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality

Time frame: 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

Time frame: 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
Number of patients with maintenance of diagnosis of permanent AF

Time frame: 3 months

to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Acronym: Pre-CRAFT

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 29, 2013
Registry last updated: Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed