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Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02493907
Enrollment
60
Registered
2015-07-10
Start date
2014-12-31
Completion date
2018-12-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Resynchronization Therapy, Chronic Heart Failure

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.

Interventions

None listed

Sponsors

Southern Medical University, China
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Beijing Chao Yang Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Left Ventricular End Systolic Volume (LVESV)baseline and 6 monthschange in LVESV

Secondary

MeasureTime frameDescription
New York Heart Association (NYHA)baseline and 6 monthschange in NYHA
left ventricular ejection fraction (LVEF)baseline and 6 monthschange in LVEF

Countries

China

Contacts

Primary ContactJuan Lei, M.D., Ph.D.
leijuan_1@hotmail.com+86-13650894373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026