Cardiac Resynchronization Therapy
Conditions
Brief summary
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.
Interventions
DEVICEVector optimisation
Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for CRT-D implantation according to guidelines at the time of implantation * Implanted CRT-D system with SonR sensor technology * Sinus rhythm * NYHA class II-IV * Age ≥ 18 years * Written informed consent to participate in the study
Exclusion criteria
* Patients having received a CRT system without SonR sensor technology * Patients with an insufficient SonR signal * Confirmed pregnancy * Age \< 18 years * Life expectancy \< 1 year * Atrial fibrillation / atrial flutter at the time of enrollment * Unability to give informed consent * Participation in another clinical study with active therapeutic arm * Regular follow-up at the study site from enrolment to 12 months follow up not guaranteed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP decrease (-15%) | 12 months |
| VO2max (+ ≥0.7 ml/min/kg) | 12 months |
| NYHA class (improvement by ≥ 1 class) | 12 months |
| QOL (MLHF), score reduction (-15) | 12 months |
Countries
Germany
Outcome results
None listed