Quartet™ Bad Oeynhausen Trial

Congestive Heart Failure Clinical Trial

— QUOTA  

Official title:

Quartet™ Bad Oeynhausen Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850264
• Other study ID #: HDZNRW_KA_002_KJG
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Application of quadripolar / bipolar LV electrodes

Locations

Country	Name	City	State
Germany	Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum	Bad Oeynhausen

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in peak oxygen consumption		6 months
Primary	Reduction of New York Heart Association (NYHA) functional class		6 months
Primary	Survival		6 months