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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
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
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.

Condition or disease
Atrial Fibrillation Heart Failure

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930695


Locations
Germany
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
St. Marien-Hospital Lünen
Lünen, Germany, 44534
Deutsches Herzzentrum München
München, Germany, 80636
DRK Mölln-Ratzeburg
Ratzeburg, Germany, 23909
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Biotronik SE & Co. KG
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
Study Chair: Christian Sticherling, Prof. Dr. Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

Publications of Results:
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01930695     History of Changes
Other Study ID Numbers: CR013
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Biotronik SE & Co. KG:
DX functionality
Atrial fibrillation
CRT-D indication

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes