Clinical trial NCT04988243: Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
Official title: Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Aortic Valve Stenosis
Lead sponsor: CCRF Inc., Beijing, China
Sponsor class: INDUSTRY
Collaborators: name: Hangzhou Qiming Medical Instrument Co., Ltd
First posted: 2021-08-03
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Retrospective subjects were subjects who had completed transcatheter aortic valve replacement at the beginning of the study. Previous data such as demography and treatment of subjects before the start of the study will be realized by reviewing medical records. Follow up data not traceable to medical records and follow-up data after the start of the study, Prospective subjects were those who were undergoing or planned to undergo transcatheter aortic valve replacement at the beginning of the study. Subjects were enrolled from the beginning of the first case to one year later. The demographic, treatment and follow-up data of subjects will be collected through clinical follow-up or telephone follow-up
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Severe aortic valve stenosis, defined as follows:

   1. 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)
   2. 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%
2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
4. Be able to contact the subjects or their legal guardians / relatives;
5. 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:

1. Contraindications to any artificial biological valve implantation;
2. Any known allergies or contraindications;

   * Aspirin or heparin and bivalirudin;
   * Tigrelol and clopidogrel;
   * Nickel titanium alloy;
   * Contrast medium;
3. The patient is currently participating in drug or device research;
4. The patient is pregnant or lactating;
5. Aortic annulus diameter \< 17 mm or \> 32 mm;
6. The diameter of approach vessel was less than 5.0mm;
7. The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;

Primary outcomes:
measure: Primary end point: the incidence of all-cause death 12 months after operation
timeFrame: 12 months after aortic valve replacement
Secondary outcomes:
measure: The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
timeFrame: Within 30 days after aortic valve replacement
measure: The implantation rate of permanent pacemaker within 30 days;
timeFrame: Within 30 days after aortic valve replacement
measure: All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years
timeFrame: 12 months and within 2, 3, 4 and 5 years
measure: the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;
timeFrame: 12 months and within 2, 3, 4 and 5 years
measure: The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;
timeFrame: 12 months and within 2, 3, 4 and 5 years
measure: The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
timeFrame: 12 months and within 2, 3, 4 and 5 years
measure: The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
timeFrame: 12 months and within 2, 3, 4 and 5 years
measure: The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
timeFrame: 12 months after aortic valve replacement
Other outcomes:
Locations:
Study officials:
References: