Back to resultsMulti Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
Primary Purpose
Severe Aortic Valve Stenosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
All aortic valve products on the market
Sponsored by
About this trial
This is an interventional treatment trial for Severe Aortic Valve Stenosis
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Prospective and retrospective study of subjects undergoing aortic valve surgery
Arm Description
This study is a prospective / retrospective, multicenter, and observational study after listing. The researchers can initially determine that they can be enrolled in the study according to the history diagnosis of the subjects. After fully informed, they sign informed consent form. After the evaluation of the researchers, they meet the TAVR selection requirements, and register the subjects in multiple centers at the same time
Outcomes
Primary Outcome Measures
Primary end point: the incidence of all-cause death 12 months after operation
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 Outcome Measures
The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
The implantation rate of permanent pacemaker within 30 days;
The implantation rate of permanent pacemaker within 30 days;
All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years
All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years;
the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;
the incidence of life-threatening bleeding within 12 months and 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;
The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;
The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
Full Information
NCT ID
NCT04988243
First Posted
July 23, 2021
Last Updated
August 1, 2021
Sponsor
CCRF Inc., Beijing, China
Collaborators
Hangzhou Qiming Medical Instrument Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04988243
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CCRF Inc., Beijing, China
Collaborators
Hangzhou Qiming Medical Instrument Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Valve Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective and retrospective study of subjects undergoing aortic valve surgery
Arm Type
Other
Arm Description
This study is a prospective / retrospective, multicenter, and observational study after listing. The researchers can initially determine that they can be enrolled in the study according to the history diagnosis of the subjects. After fully informed, they sign informed consent form. After the evaluation of the researchers, they meet the TAVR selection requirements, and register the subjects in multiple centers at the same time
Intervention Type
Other
Intervention Name(s)
All aortic valve products on the market
Intervention Description
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 Outcome Measure Information:
Title
Primary end point: the incidence of all-cause death 12 months after operation
Description
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
Time Frame
12 months after aortic valve replacement
Secondary Outcome Measure Information:
Title
The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);
Description
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
Title
The implantation rate of permanent pacemaker within 30 days;
Description
The implantation rate of permanent pacemaker within 30 days;
Time Frame
Within 30 days after aortic valve replacement
Title
All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years
Description
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
Title
the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;
Description
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
Title
The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;
Description
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
Title
The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;
Description
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
Title
The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);
Description
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
Title
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
Description
The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;
Time Frame
12 months after aortic valve replacement
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Learn more about this trial
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
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