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NCT Number: NCT06379386

Long-term Prognosis and Valve Durability of TAVR

This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.

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Key information

Conditions

Aortic Valve Stenosis and Insufficiency Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.

  • Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
  • 1. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
  • 2. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

Exclusion criteria

  • 1. Patients who cannot provide informed consent
  • 2. Patients who are participating in other clinical trials

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

A total of 1000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled. Clinical follow-up will be conducted in the periprocedural and after TAVR at 1 month, 5 years, and 10 years

Other names: Transcatheter aortic valve implantation

Primary outcomes

  1. All-casuse mortality

    Time frame: 5 years

    All-casuse mortality including cardiac death and non-cardiac death

  2. Valve-related long-term clinical efficacy

    Time frame: 5 years

    • Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration
    • Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
    • Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)

Secondary outcomes

  1. Combined early safety and clinical efficacy outcomes

    Time frame: 30 days

    Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events

  2. Rate of technical success

    Time frame: at exit from procedure room

    • Freedom from mortality
    • Successful access, delivery of the device, and retrieval of the delivery system
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location
    • Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

  3. Rate of device success

    Time frame: discharge or 30 days

    • Technical success
    • Freedom from mortality
    • Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
    • Intended performance of the valve (mean gradient<20mmHg, and less than moderate aortic regurgitation)

  4. Combined clinical efficacy outcomes

    Time frame: 5 years and 10 years

    Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization

  5. Valve-related long-term clinical efficacy

    Time frame: 10 years

    • Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration
    • Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
    • Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)

Study contacts

Contact information is provided by the study sponsor or research team.

Rutao Wang, M.D, Ph.D

CONTACT

[email protected]

+86-15091095796

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study

Important dates

Study start
2016
Primary completion
2025
Study completion
2030
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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