NCT01850264

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

5.8 years

First QC Date

December 19, 2012

Last Update Submit

January 28, 2019

Conditions

Congestive Heart FailureCardiac Resynchronization Therapy

Keywords

cardiac resynchronization therapy; heart failure, congestive

Outcome Measures

Primary Outcomes (3)

  • Increase in peak oxygen consumption

    6 months

  • Reduction of New York Heart Association (NYHA) functional class

    6 months

  • Survival

    6 months

Study Arms (2)

Quadripolar LV electrode

ACTIVE COMPARATOR

Application of a quadripolar LV electrode

Device: Application of quadripolar / bipolar LV electrodes

Bipolar LV electrode

ACTIVE COMPARATOR

Application of a bipolar LV electrode

Device: Application of quadripolar / bipolar LV electrodes

Interventions

Application of quadripolar / bipolar LV electrodesDEVICE
Bipolar LV electrodeQuadripolar LV electrode

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Klaus-Juergen Gutleben, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior cardiologist

Study Record Dates

First Submitted

December 19, 2012

First Posted

May 9, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

DE(1)