Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

• Sponsor: Yuksek Ihtisas Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02247427
• Collaborator: (none)
• Enrollment: 19
• Arms: 2
• Duration (Months): 65

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical/Echocardiographic outcome [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 [12 months]

   Number of participants experiencing mortality

2. Heart failure hospitalization [12 months]

   Number of participants experiencing heart failure hospitalization

3. Cardiac Resynchronization Therapy Device intervention [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• super response to Cardiac Resynchronization Therapy

• near normal Left ventricular ejection fraction

• 99% pacing

Exclusion Criteria:

• <99% pacing

• atrial fibrillation

• ischemic cardiomyopathy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yuksek Ihtisas Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Serkan Cay, Associate Professor, Yuksek Ihtisas Hospital
• ClinicalTrials.gov Identifier: NCT02247427
• Other Study ID Numbers: TYIH-132
• First Posted: Sep 25, 2014
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Serkan Cay, Associate Professor, Yuksek Ihtisas Hospital: Heart failure; Super responder
• Additional relevant MeSH terms: Cardiomyopathies

Study Results

No Results Posted as of Sep 25, 2014