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

April 10, 2018 updated by: Biotronik SE & Co. KG
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz- und Gefässzentrum Bad Bevensen
      • Lünen, Germany, 44534
        • St. Marien-Hospital Lünen
      • München, Germany, 80636
        • Deutsches Herzzentrum München
      • Ratzeburg, Germany, 23909
        • DRK Mölln-Ratzeburg
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitatsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

  • Study Chair: Christian Sticherling, Prof. Dr., Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 26, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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