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Quartet™ Bad Oeynhausen Trial (QUOTA)

Primary Purpose

Congestive Heart Failure, Cardiac Resynchronization Therapy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Application of quadripolar / bipolar LV electrodes
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring cardiac resynchronization therapy; heart failure, congestive

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadripolar LV electrode

Bipolar LV electrode

Arm Description

Application of a quadripolar LV electrode

Application of a bipolar LV electrode

Outcomes

Primary Outcome Measures

Increase in peak oxygen consumption
Reduction of New York Heart Association (NYHA) functional class
Survival

Secondary Outcome Measures

Full Information

First Posted
December 19, 2012
Last Updated
January 28, 2019
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT01850264
Brief Title
Quartet™ Bad Oeynhausen Trial
Acronym
QUOTA
Official Title
Quartet™ Bad Oeynhausen Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Cardiac Resynchronization Therapy
Keywords
cardiac resynchronization therapy; heart failure, congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadripolar LV electrode
Arm Type
Active Comparator
Arm Description
Application of a quadripolar LV electrode
Arm Title
Bipolar LV electrode
Arm Type
Active Comparator
Arm Description
Application of a bipolar LV electrode
Intervention Type
Device
Intervention Name(s)
Application of quadripolar / bipolar LV electrodes
Primary Outcome Measure Information:
Title
Increase in peak oxygen consumption
Time Frame
6 months
Title
Reduction of New York Heart Association (NYHA) functional class
Time Frame
6 months
Title
Survival
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus-Juergen Gutleben, M.D.
Organizational Affiliation
Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

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Quartet™ Bad Oeynhausen Trial

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