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Clinical Trials/NCT02493907
NCT02493907
Unknown
N/A

A Prospective Clinical Trial of Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy in Chinese With Heart Failure

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country60 target enrollmentDecember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
60
Locations
1
Primary Endpoint
Left Ventricular End Systolic Volume (LVESV)
Last Updated
9 years ago

Overview

Brief Summary

Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with severe systolic heart failure (HF) and ventricular desynchronization. Despite the consistently observed structural and functional improvements as well as reductions in HF events and mortality in large multicenter randomized trials, 30% patients remain classified as nonresponders. Present evidences showed that QRS duration was the most effective parameter to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS duration could be influenced by obesity and gender. Accordingly, the simple QRS interval width of body surface electrocardiograph should not be the most satisfactory parameter for screening patients suitable for CRT. Recent study showed that left ventricular electrical delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV), predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can increase the likelihood of structural response to CRT. However, it is unclear whether it is suitable for Chinese patients. The investigators would like to validate this relation in a Chinese population and explore if a corrected QLV might do better to predict the responsivity of CRT.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jingfeng Wang

subdecanal

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

  • •More than 18 Years
  • Informed consent signed
  • NYHA class ≥ II, an ejection fraction of ≤ 0.35, QRS duration of ≥ 150 milliseconds with Non-LBBB) or ≥ 120 milliseconds with LBBB, who treated with CRT
  • The Estimated survival time was more than one year
  • sinus rhythm, pacemaker independent

Exclusion Criteria

  • •NYHA class I symptoms
  • Severe liver or kidney dysfunction
  • Valvular heart disease
  • Pregnancy or lactation women
  • percutaneous coronary intervention (PCI) or cardiac artery bypass graft (CABG) within 3 month
  • Have malignant tumors and the Estimated survival time was less than one year
  • an enzyme-positive myocardial infarction within 3 months before enrollment, or atrial fibrillation
  • any reasons cannot complete follow-up; Or researchers think that don't suit to be included in the research of other conditions

Outcomes

Primary Outcomes

Left Ventricular End Systolic Volume (LVESV)

Time Frame: baseline and 6 months

change in LVESV

Secondary Outcomes

  • left ventricular ejection fraction (LVEF)(baseline and 6 months)
  • New York Heart Association (NYHA)(baseline and 6 months)

Study Sites (1)

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