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Clinical Trials/NCT04397224
NCT04397224
Unknown
Not Applicable

Prospective Multicenter Observation Study on the Serial Changes in Ventriculo-ventricular Conduction Times According to Cardiac-resynchronization Therapy Response

Samsung Medical Center6 sites in 1 country100 target enrollmentJuly 20, 2018
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Samsung Medical Center
Enrollment
100
Locations
6
Primary Endpoint
Serial change of ventriculo-ventricular conduction times
Last Updated
4 years ago

Overview

Brief Summary

This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.

Registry
clinicaltrials.gov
Start Date
July 20, 2018
End Date
July 20, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant

Exclusion Criteria

  • Myocardial infarction, unstable angina within 40 days prior the enrollment
  • Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
  • Primary valvular disease requiring surgical correction
  • Pregnant or are planning during the duration of the investigation
  • Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
  • Post-cardiac transplantation
  • Life expectancy \< 12 months
  • Currently participating in any other clinical investigation except for observational registry

Outcomes

Primary Outcomes

Serial change of ventriculo-ventricular conduction times

Time Frame: from enrollment to last follow-up (2 years)

Reduction or extension of ventriculo-ventricular conduction times

Study Sites (6)

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