Efface: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
indication for CRT-D implantation / upgrade
-
written informed consent
Exclusion Criteria:
-
pregnancy
-
age < 18 years
-
patients, who cannot visit the routine follow ups (within first 3.5months)
-
participants to other studies with active treatment arm
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medizinische Einrichtungen der RWTH Aachen | Aachen | Germany | 52074 | |
2 | Hufeland Klinikum GmbH | Bad Langensalza | Germany | 99947 | |
3 | Cardioangiologisches Centrum Bethanien | Frankfurt am Main | Germany | 60389 | |
4 | Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen | Gießen | Germany | 35392 | |
5 | Universitäres Herzzentrum Hamburg GmbH (UHZ) | Hamburg | Germany | 20246 | |
6 | Katholisches Krankenhaus Marienhospital Universitätsklinik | Herne | Germany | 44625 | |
7 | Klinikum Kassel gGmbH | Kassel | Germany | 34125 | |
8 | Universitätsklinikum Leipzig AÖR | Leipzig | Germany | 04103 | |
9 | Niels-Stensen-Kliniken Marienhospital | Osnabrück | Germany | 49074 | |
10 | Klinikum Dorothea Christiane Erxleben GmbH | Quedlinburg | Germany | 06484 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Norbert Klein, Dr. med., Universitätsklinikum Leipzig AÖR
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T86