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

Biotronik

Status: Completed

Conditions: Atrial Fibrillation; Heart Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01930695

CR013

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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