SonR Based Stimulation-VECtor OPTimisation in CRT Patients

Cardiac Resynchronization Therapy Clinical Trial

— VECTOPT  

Official title:

Effect of SonR Based Stimulation-VECtor OPTimisation in Patients With Chronically Implanted Cardiac Resynchronization Devices

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03092349
• Other study ID #: HDZNRW-KA-007_KJG
• Status: Terminated
• Start date: January 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy

Intervention

Device:
• Vector optimisation
Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP decrease (-15%)		12 months
Primary	VO2max (+ =0.7 ml/min/kg)		12 months
Primary	NYHA class (improvement by = 1 class)		12 months
Primary	QOL (MLHF), score reduction (-15)		12 months