SonR Based Stimulation-VECtor OPTimisation in CRT Patients (VECTOPT)

Heart and Diabetes Center North-Rhine Westfalia

Status: Terminated

Conditions: Cardiac Resynchronization Therapy

Treatments: Device: Vector optimisation

Study type: Observational

Funder types: Other

Identifiers

NCT03092349

HDZNRW-KA-007_KJG

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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