SonR Based Stimulation-VECtor OPTimisation in CRT Patients | NCT03092349

Studies
SonR Based Stimulation-VECtor OPTimisation in CRT Patients

NCT03092349

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Status

Terminated

Last Update Posted

Feb 6, 2019Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Cardiac Resynchronization Therapy

Interventions

Vector optimisation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator has left study site

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2019

Last Update Posted Date

Feb 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vector optimisation	Device	Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus-Jürgen Gutleben, MD	Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Diabeteszentrum NRW		Bad Oeynhausen		32545	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided