Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
- Conditions
- Heart Failure
- Registration Number
- NCT01244308
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- indication for CRT-D implantation / upgrade
- written informed consent
- pregnancy
- age < 18 years
- patients, who cannot visit the routine follow ups (within first 3.5months)
- participants to other studies with active treatment arm
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of patients with at least one acceptable LV pacing configuration. First Follow Up after hospital discharge (approx. 1-3 months) Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold \<=2.5V@0.5ms AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance \>=200 Ohms.
Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen
🇩🇪Gießen, Germany
Medizinische Einrichtungen der RWTH Aachen
🇩🇪Aachen, Germany
Niels-Stensen-Kliniken Marienhospital
🇩🇪Osnabrück, Germany
Katholisches Krankenhaus Marienhospital Universitätsklinik
🇩🇪Herne, Germany
Universitätsklinikum Leipzig AÖR
🇩🇪Leipzig, Germany
Universitäres Herzzentrum Hamburg GmbH (UHZ)
🇩🇪Hamburg, Germany
Hufeland Klinikum GmbH
🇩🇪Bad Langensalza, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt am Main, Germany
Klinikum Kassel gGmbH
🇩🇪Kassel, Germany
Klinikum Dorothea Christiane Erxleben GmbH
🇩🇪Quedlinburg, Germany