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Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.
Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.
Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadripolar lead | All participants receive a CRT-D system with quadripolar lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadripolar LV lead (Quartet) | Device | All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least one acceptable lead vector | Definition of acceptable lead vector: Any LV vector that complies in both tested body positions with both criteria:
| Pre hospital discharge (PHD) to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Minnesota living with heart failure questionaire | Baseline to 3 months |
| Phrenic nerve stimulation (PNS) |
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Brachmann, Prof. | Klinikum Coburg GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Coburg GmbH | Coburg | 96450 | Germany | |||
| Evangelisches Krankenhaus Kalk |
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|
| PHD to 3 months |
| LV pacing thresholds |
| PHD to 3 months |
| Number of acceptable LV lead vectors per patient | PHD to 3 months |
| Finally programmed LV lead vector |
| PHD to 3 months |
| Cologne |
| 51103 |
| Germany |
| Krankenhaus Mörsenbroich-Rath GmbH | Düsseldorf | 40472 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt am Main | 60389 | Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem | Göttingen | 37073 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | 67063 | Germany |
| St.-Marien-Hospital GmbH | Lünen | 44534 | Germany |
| Klinikum Magdeburg gGmbH | Magdeburg | 39130 | Germany |
| Marien-Hospital | Marl | 45768 | Germany |
| Klinikum Großhadern der Ludwig-Maximilians-Universität München | München | 81377 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Niels-Stensen-Kliniken Marienhospital Osnabrück | Osnabrück | 49074 | Germany |
| Klinikum Dorothea Christiane Erxleben GmbH | Quedlinburg | 06484 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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