An observational study in Heart Failure, sponsored by Abbott Medical Devices. Completed at 16 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices · Observational
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:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 337 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.
Exclusion Criteria:
All participants receive a CRT-D system with quadripolar lead
Device: quadripolar LV lead (Quartet)
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Also known as: Quartet
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
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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