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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01930695
First received: August 21, 2013
Last updated: August 20, 2014
Last verified: February 2014
  Purpose

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
Atrial Fibrillation
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Quality of IEGM recording [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    to investigate whether the diagnosis of permanent AF at enrollment is maintained after device implantation


Enrollment: 18
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01930695     History of Changes
Other Study ID Numbers: CR013
Study First Received: August 21, 2013
Last Updated: August 20, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 18, 2014