Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

September 18, 2014 updated by: Serkan Cay, Yuksek Ihtisas Hospital

Midterm 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <99% pacing
  • atrial fibrillation
  • ischemic cardiomyopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months
Number of participants experiencing mortality
12 months
Heart failure hospitalization
Time Frame: 12 months
Number of participants experiencing heart failure hospitalization
12 months
Cardiac Resynchronization Therapy Device intervention
Time Frame: 12 months
Heart failure hospitalization Cardiac Resynchronization Therapy Device intervention for detected episodes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuksek Ihtisas Hospital

Investigators

  • Principal Investigator: Serkan Cay, MD, Yuksek Ihtisas Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYIH-132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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