Quartet™ Bad Oeynhausen Trial | NCT01850264

Studies
Quartet™ Bad Oeynhausen Trial

NCT01850264

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Status

Completed

Last Update Posted

Jan 30, 2019Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Congestive Heart Failure
Cardiac Resynchronization Therapy

Interventions

Application of quadripolar / bipolar LV electrodes

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 9, 2013Estimated

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

Jan 28, 2019

Last Update Posted Date

Jan 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Juergen Gutleben, Senior cardiologist, Heart and Diabetes Center North-Rhine WestfaliaPrincipal Investigator

Lead Sponsor

Heart and Diabetes Center North-Rhine WestfaliaOTHER

Collaborators

Not provided

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

Primary objective of this study is to evaluate whether the use of a quadripolar left ventricular (LV) electrode compared to a standard bipolar LV electrode leads to lower non-responder rates in patients undergoing cardiac resynchronization therapy (CRT)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quadripolar LV electrode	Active Comparator	Application of a quadripolar LV electrode	Device: Application of quadripolar / bipolar LV electrodes
Bipolar LV electrode	Active Comparator	Application of a bipolar LV electrode	Device: Application of quadripolar / bipolar LV electrodes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Application of quadripolar / bipolar LV electrodes	Device		Bipolar LV electrode Quadripolar LV electrode

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in peak oxygen consumption		6 months
Reduction of New York Heart Association (NYHA) functional class		6 months
Survival		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for CRT-D implantation according to current guidelines
Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
Sinus rhythm
NYHA II-IV
Age ≥ 18 years
Written informed consent to participate in the study

Exclusion Criteria:

Right bundle brunch block
Valvular cardiomyopathy
Patient receiving a non-transvenous LV electrode
Known pregnancy
Age < 18 years
Life expectancy < 1 year
Atrial fibrillation / atrial flutter at the time of enrolment
Inability to provide informed consent
Participation in another study with active therapeutic arm
Regular follow-up in the study center within the first 6 months after implantation not guaranteed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus-Juergen Gutleben, M.D.	Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum		Bad Oeynhausen		32545	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided