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Clinical Trials in China / NCT06595992
Recruiting Observational

Prospective Observational Cohort Study of Moderate Aortic Valve Disease

NCT06595992 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2024-09-01
Last updated
2024-09-19

Condition(s) studied

Moderate Aortic Valve StenosisModerate Aortic Valve RegurgitationAortic Valve Disease

Study summary

The objective of this research is to evaluate and predict the progression of moderate aortic stenosis and regurgitation from clinical characterization, biological, echocardiographic, and computed tomography (CT) et. al. Additionally, try to analyze the potential impact of device or drug therapy on the progression of the conditions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * At least 18 years old * Be willing and able to provide informed consent to participate in the study * Patient has moderate aortic valve diseases with echocardiographically derived criteria Exclusion Criteria: * Severe aortic valve diseases with echocardiographically derived criteria or planned cardiac surgery or likely need for surgery within 6 months * Patients who have undergone elective transfemoral transcatheter aortic valve replacement * Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.) * Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit) * Acute pulmonary oedema or cardiogenic shock * The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects * The patient is currently participating in another randomized study

Primary outcome measure(s)

  • All cause mortality — 1-year, 3-year, and 5-year at follow-up
  • Re-hospitalization related to heart failure. — 1-year, 3-year, and 5-year at follow-up
  • Aortic valve replacement — 1-year, 3-year, and 5-year at follow-up
    Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement.
  • Stroke — 1-year, 3-year, and 5-year at follow-up
    Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease Enrolling by invitation
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction Recruiting
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation Recruiting
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL） Starting soon
TAVR for Aortic Valve Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06595992 on ClinicalTrials.gov ↗ ← All trials in China