SonR Based Stimulation-VECtor OPTimisation in CRT Patients

NCT03092349 | Terminated

• 1 other identifier: HDZNRW-KA-007_KJG
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Vector optimisation DEVICE

Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Study Officials

• Klaus-Jürgen Gutleben, MD

  Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)