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

NCT01930695 | Completed

• 1 other identifier: CR013
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 5

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

DX functionality; Atrial fibrillation; CRT-D indication

Outcome Measures

Primary Outcomes (4)

• Quality of IEGM recording

  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

  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

  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

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

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (5)

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

St. Marien-Hospital Lünen

Lünen, 44534, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

DRK Mölln-Ratzeburg

Ratzeburg, 23909, Germany

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Sticherling C, Muller D, Schaer BA, Kruger S, Kolb C; Pre-CRAFT investigators. Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy. Indian Pacing Electrophysiol J. 2018 Jul-Aug;18(4):140-145. doi: 10.1016/j.ipej.2018.03.005. Epub 2018 Mar 27.

  PMID: 29596906 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Sticherling, Prof. Dr.

  Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

DE (4); CH (1)