Quartet™ Bad Oeynhausen Trial (QUOTA)

Heart and Diabetes Center North-Rhine Westfalia

Status: Completed

Conditions: Cardiac Resynchronization Therapy; Congestive Heart Failure

Treatments: Device: Application of quadripolar / bipolar LV electrodes

Study type: Interventional

Funder types: Other

Identifiers

NCT01850264

HDZNRW_KA_002_KJG

Details and patient eligibility

About

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)

Enrollment: 81 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Quadripolar LV electrode

Active Comparator group

Description:

Application of a quadripolar LV electrode

Treatment:

Device: Application of quadripolar / bipolar LV electrodes

Bipolar LV electrode

Active Comparator group

Description:

Application of a bipolar LV electrode

Treatment:

Device: Application of quadripolar / bipolar LV electrodes