SonR Based Stimulation-VECtor OPTimisation in CRT Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vector optimisation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No