Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy

• Conditions: Cardiac Resynchronization Therapy; Chronic Heart Failure

• Registration Number: NCT02493907
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left Ventricular End Systolic Volume (LVESV)	baseline and 6 months	change in LVESV

Secondary Outcome Measures

Name	Time	Method
left ventricular ejection fraction (LVEF)	baseline and 6 months	change in LVEF
New York Heart Association (NYHA)	baseline and 6 months	change in NYHA

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China