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CompletedNCT02247427Updated Sep 25, 2014

Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

A Phase 2/3 interventional study of Cardiac Resynchronization Therapy Device in Cardiomyopathy, sponsored by Yuksek Ihtisas Hospital. Completed. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by Yuksek Ihtisas Hospital · Phase 2/3 and Interventional

Phase
Phase 2/3
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Cardiomyopathy

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Keywords

  • Heart failure
  • Super responder
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 19 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Yuksek Ihtisas Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<99% pacing
  • atrial fibrillation
  • ischemic cardiomyopathy
05

Study design

Phase
Phase 2 / Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Off-pace group

    Deactivated device group

    Device: Cardiac Resynchronization Therapy Device

  • No intervention
    On-Pace group

    Ongoing device activity group

Interventions

  • DeviceCardiac Resynchronization Therapy Device

    Cardiac Resynchronization Therapy Device pacing activity, on or off

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Mortality

    Number of participants experiencing mortality

    Time frame: 12 months

  2. Heart failure hospitalization

    Number of participants experiencing heart failure hospitalization

    Time frame: 12 months

  3. Cardiac Resynchronization Therapy Device intervention

    Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02247427
Lead sponsor
Yuksek Ihtisas Hospital
Responsible party
Serkan Cay (Associate Professor, Yuksek Ihtisas Hospital) — Principal investigator
First posted
Sep 25, 2014
Start date
Jan 2009
Primary completion
Jun 2013
Completion
Jun 2014
Last update
Sep 25, 2014

Study contacts

Serkan Cay, MD
principal investigator · Yuksek Ihtisas Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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