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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: Vector optimisation

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a CRT-D system providing the possibility of SonR-based optimisation of AV-D and VV-D

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Investigators: Principal Investigator: Klaus-Jürgen Gutleben, MD, Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HDZNRW-KA-007_KJG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No