NCT02247427

Brief Summary

The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

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

Study Start

First participant enrolled

January 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

4.4 years

First QC Date

September 16, 2014

Last Update Submit

September 18, 2014

Conditions

Cardiomyopathy

Keywords

Heart failureSuper responder

Outcome Measures

Primary Outcomes (1)

  • Clinical/Echocardiographic outcome

    Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter.

    12 months

Secondary Outcomes (3)

  • Mortality

    12 months

  • Heart failure hospitalization

    12 months

  • Cardiac Resynchronization Therapy Device intervention

    12 months

Study Arms (2)

Off-pace group

EXPERIMENTAL

Deactivated device group

Device: Cardiac Resynchronization Therapy Device

On-Pace group

NO INTERVENTION

Ongoing device activity group

Interventions

Cardiac Resynchronization Therapy DeviceDEVICE

Cardiac Resynchronization Therapy Device pacing activity, on or off

Off-pace group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • super response to Cardiac Resynchronization Therapy
  • near normal Left ventricular ejection fraction
  • \>99% pacing

You may not qualify if:

  • \<99% pacing
  • atrial fibrillation
  • ischemic cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CardiomyopathiesHeart Failure

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pacemaker, ArtificialElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Serkan Cay, MD

    Yuksek Ihtisas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 25, 2014

Study Start

January 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09