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NCT Number: NCT04988243

Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China

The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.

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Key information

Conditions

Severe Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a prospective / retrospective, multicenterstudy after listing. The researchers preliminarily confirmed that they could be enrolled in this study according to the diagnosis of the subjects' medical history. After fully informed, they signed the informed consent, and met the TAVR inclusion requirements (see the inclusion criteria for details). At the same time, they registered the subjects in multiple centers. After the start of the trial, the participants were enrolled in the study, All the subjects who met the inclusion criteria but did not meet the discharge criteria were registered in the central registration system. The patients were followed up for 30 days, 6 months and 12 months, and followed up by telephone for 2, 3, 4 and 5 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe aortic valve stenosis, defined as follows:
  • Symptomatic patients:
  • The mean differential pressure measured by echocardiography ≥ 40mm Hg
  • Or peak aortic ejection ≥ 4.0 m / S
  • Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2)
  • Asymptomatic patients:
  • Severe aortic stenosis and aortic valve area ≤ 1.0cm ²（ 6 cm2 / m2) with aortic ejection peak value ≥ 5.0 M / s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;
  • Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia;
  • Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF < 50%
  • Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
  • The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
  • Be able to contact the subjects or their legal guardians / relatives;
  • The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)

Note: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group.

Exclusion criteria

  • Contraindications to any artificial biological valve implantation;
  • Any known allergies or contraindications;
  • Aspirin or heparin and bivalirudin;
  • Tigrelol and clopidogrel;
  • Nickel titanium alloy;
  • Contrast medium;
  • The patient is currently participating in drug or device research;
  • The patient is pregnant or lactating;
  • Aortic annulus diameter < 17 mm or > 32 mm;
  • The diameter of approach vessel was less than 5.0mm;
  • The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;

Treatment and study plan

All aortic valve products on the market

Other
  • Subjects with severe aortic valve stenosis
  • Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
  • The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
  • Be able to contact the subjects or their legal guardians / relatives;
  • The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)

Sign the informed consent form, then check the inclusion and exclusion criteria, register after meeting the criteria, obtain the registration number, perform aortic valve replacement surgery, follow-up 24 hours, discharge, 30 days, 1 year, 2 years, 3 years, 4 years and 5 years after operation according to the test requirements, and carry out relevant follow-up according to the scheme requirements to collect data

Primary outcomes

  1. Primary end point: the incidence of all-cause death 12 months after operation

    Time frame: 12 months after aortic valve replacement

    After subjects completed aortic valve replacement surgery, whether prospectively or retrospectively, all-cause mortality at 12 months after operation was collected according to the time node of subjects' enrollment

Secondary outcomes

  1. The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);

    Time frame: Within 30 days after aortic valve replacement

    The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);

  2. The implantation rate of permanent pacemaker within 30 days;

    Time frame: Within 30 days after aortic valve replacement

    The implantation rate of permanent pacemaker within 30 days;

  3. All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years

    Time frame: 12 months and within 2, 3, 4 and 5 years

    All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years;

  4. the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;

    Time frame: 12 months and within 2, 3, 4 and 5 years

    the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;

  5. The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;

    Time frame: 12 months and within 2, 3, 4 and 5 years

    The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;

  6. The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;

    Time frame: 12 months and within 2, 3, 4 and 5 years

    The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;

  7. The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);

    Time frame: 12 months and within 2, 3, 4 and 5 years

    The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);

  8. The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;

    Time frame: 12 months after aortic valve replacement

    The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;

Sponsors and collaborators

Lead sponsor

CCRF Inc., Beijing, China

Industry

Collaborators

  • Hangzhou Qiming Medical Instrument Co., Ltd

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2028
First posted
Aug 3, 2021
Registry last updated
Aug 3, 2021

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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