Quartet™ Bad Oeynhausen Trial

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)

Completed

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Key information

Conditions

Congestive Heart Failure Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bad Oeynhausen, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of quadripolar / bipolar LV electrodes

Device

Primary outcomes

Increase in peak oxygen consumption

Time frame: 6 months
Reduction of New York Heart Association (NYHA) functional class

Time frame: 6 months
Survival

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Acronym: QUOTA

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: May 9, 2013
Registry last updated: Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed