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

Heart Failure Clinical Trial

— Pre-CRAFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930695
• Other study ID #: CR013
• Status: Completed
• First received: August 21, 2013
• Last updated: April 10, 2018
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2018
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Locations

Country	Name	City	State
Germany	Herz- und Gefäßzentrum Bad Bevensen	Bad Bevensen
Germany	St. Marien-Hospital Lünen	Lünen
Germany	Deutsches Herzzentrum München	München
Germany	DRK Mölln-Ratzeburg	Ratzeburg
Switzerland	Universitätsspital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG	Clinical Trial Unit, University Hospital Basel, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Sticherling C, Müller D, Schaer BA, Krüger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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