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
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring cardiac resynchronization therapy; heart failure, congestive
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
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
NCT ID
NCT01850264
First Posted
December 19, 2012
Last Updated
January 28, 2019
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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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