Clinical trial NCT01930695: Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
Official title: Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Heart Failure
Keywords: DX functionality
Atrial fibrillation
CRT-D indication
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2013-08-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure patients with CRT-D indication according to current ESC guidelines and permanent atrial fibrillation

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.


Eligibility 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

Primary outcomes:
measure: Quality of IEGM recording
timeFrame: 3 months
measure: Safety of the Lumax 640/740 HF-T with DX functionality based on the Serious Adverse Device Effects related to the DX functionality
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Number of patients with maintenance of diagnosis of permanent AF
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Bevensen
country: Germany
facility: Herz- und Gefäßzentrum Bad Bevensen
city: Lünen
country: Germany
facility: St. Marien-Hospital Lünen
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Ratzeburg
country: Germany
facility: DRK Mölln-Ratzeburg
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
name: Christian Sticherling, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.