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Completed

NCT Number: NCT02247427

Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

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

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases Heart Failure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <99% pacing
  • atrial fibrillation
  • ischemic cardiomyopathy

Treatment and study plan

Cardiac Resynchronization Therapy Device

Device

Cardiac Resynchronization Therapy Device pacing activity, on or off

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas Hospital

Other

Registry information

Official study title

Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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