Quartet™ Bad Oeynhausen Trial (QUOTA)

January 28, 2019 updated by: Klaus Juergen Gutleben, Heart and Diabetes Center North-Rhine Westfalia
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quadripolar LV electrode
Application of a quadripolar LV electrode
Device: Application of quadripolar / bipolar LV electrodes
Active Comparator: Bipolar LV electrode
Application of a bipolar LV electrode
Device: Application of quadripolar / bipolar LV electrodes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW_KA_002_KJG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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