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Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

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ClinicalTrials.gov Identifier: NCT02247427
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Serkan Cay, Yuksek Ihtisas Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Device: Cardiac Resynchronization Therapy Device Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders
Study Start Date : January 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Off-pace group
Deactivated device group
Device: Cardiac Resynchronization Therapy Device
Cardiac Resynchronization Therapy Device pacing activity, on or off

No Intervention: On-Pace group
Ongoing device activity group



Primary Outcome Measures :
  1. Clinical/Echocardiographic outcome [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 months ]
    Number of participants experiencing mortality

  2. Heart failure hospitalization [ Time Frame: 12 months ]
    Number of participants experiencing heart failure hospitalization

  3. Cardiac Resynchronization Therapy Device intervention [ Time Frame: 12 months ]
    Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <99% pacing
  • atrial fibrillation
  • ischemic cardiomyopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247427


Sponsors and Collaborators
Yuksek Ihtisas Hospital
Investigators
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Principal Investigator: Serkan Cay, MD Yuksek Ihtisas Hospital

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Responsible Party: Serkan Cay, Associate Professor, Yuksek Ihtisas Hospital
ClinicalTrials.gov Identifier: NCT02247427     History of Changes
Other Study ID Numbers: TYIH-132
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Serkan Cay, Yuksek Ihtisas Hospital:
Heart failure
Super responder
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases