Heart Failure
Conditions
Keywords
Hear Failure, Cardiac resynchronization, CRT-D, quadripolar
Brief summary
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.
Detailed description
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)
Interventions
DEVICEquadripolar LV lead (Quartet)
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for implantation of a CRT-D * Age \>= 18 years * Written informed consent
Exclusion criteria
* Already implanted LV or coronary sinus lead * Previous unsuccessful LV lead implant attempt * Patient is eligible for heart transplantation * Comorbidities that results in life expectancy of less than 12 months * Known pregnancy * Inability to provide written patient informed consent * Participation to another study with active treatment arm (i.e. randomized studies etc...) * Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant * Patient is not able to understand or answer the quality of life questionaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with at least one acceptable lead vector | Pre hospital discharge (PHD) to 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Baseline to 3 months | Minnesota living with heart failure questionaire |
| Phrenic nerve stimulation (PNS) | PHD to 3 months | * Incidence of PNS per LV pacing vector * Freedom from PNS for the permanently programmed LV vector |
| LV pacing thresholds | PHD to 3 months | * LV pacing thresholds per LV vector * Incidence of elevated (\>2.5V/0.5ms) LV pacing thresholds per LV vector |
| Number of acceptable LV lead vectors per patient | PHD to 3 months | — |
| Finally programmed LV lead vector | PHD to 3 months | * Need for reprogramming * Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors |
Countries
Germany
Outcome results
None listed