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: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)
Study Type
OBSERVATIONAL
Enrollment
337
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Klinikum Coburg GmbH
Coburg, Germany
Evangelisches Krankenhaus Kalk
Cologne, Germany
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, Germany
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, Germany
St.-Marien-Hospital GmbH
Lünen, Germany
...and 6 more locations
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: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5V@0.5ms
Time frame: Pre hospital discharge (PHD) to 3 months
Quality of Life
Minnesota living with heart failure questionaire
Time frame: Baseline to 3 months
Phrenic nerve stimulation (PNS)
* Incidence of PNS per LV pacing vector * Freedom from PNS for the permanently programmed LV vector
Time frame: PHD to 3 months
LV pacing thresholds
* LV pacing thresholds per LV vector * Incidence of elevated (\>2.5V/0.5ms) LV pacing thresholds per LV vector
Time frame: PHD to 3 months
Number of acceptable LV lead vectors per patient
Time frame: PHD to 3 months
Finally programmed LV lead vector
* Need for reprogramming * Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors
Time frame: PHD to 3 months
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