Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
Primary Purpose
Aortic Stenosis, Ascending Aortic Dilatation
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
type of transcatheter heart valves
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis focused on measuring Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve
Eligibility Criteria
Inclusion Criteria: Severe aortic stenosis; Transfemoral access; Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm; Anticipated life expectancy >1 year; Age ≥ 65 years. Exclusion Criteria: Dominant aortic regurgitation,; A history of SAVR or TAVR; A history of aortic surgery; Emergent TAVR.
Sites / Locations
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Self-expandable valve group
Balloon-expandable valve group
Arm Description
Patients using self-expandable valves
Patients using balloon-expandable valves
Outcomes
Primary Outcome Measures
30-day all-cause mortality
all-cause mortality within 30 days after TAVR procedure
30-day adverse aortic events
aortic death, aortic dissection, or aortic rupture
The rate of device success
Device success is defined as following:
Technical success (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)
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 <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
Secondary Outcome Measures
1-year all-cause mortality
all-cause mortality
1-year cardiovascular mortality
Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
1-year adverse aortic events
aortic death, aortic dissection, or aortic rupture
Ascending aortic diameter expansion rate ≥3mm/year
Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
Hospitalization (or re-hospitalization)
Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments <24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)
Full Information
NCT ID
NCT06009588
First Posted
August 12, 2023
Last Updated
August 20, 2023
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT06009588
Brief Title
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
Official Title
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
July 11, 2026 (Anticipated)
Study Completion Date
July 11, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
Detailed Description
Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.
Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Ascending Aortic Dilatation
Keywords
Transcatheter aortic valve replacement, Self-expandable valve, Balloon-expandable valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Self-expandable valve group vs. Balloon-expandable valve group
Masking
ParticipantInvestigator
Masking Description
Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-expandable valve group
Arm Type
Experimental
Arm Description
Patients using self-expandable valves
Arm Title
Balloon-expandable valve group
Arm Type
Experimental
Arm Description
Patients using balloon-expandable valves
Intervention Type
Device
Intervention Name(s)
type of transcatheter heart valves
Intervention Description
patients undergoing TAVR use either self-expandable valves or balloon-expandable valves
Primary Outcome Measure Information:
Title
30-day all-cause mortality
Description
all-cause mortality within 30 days after TAVR procedure
Time Frame
30 days after TAVR procedure
Title
30-day adverse aortic events
Description
aortic death, aortic dissection, or aortic rupture
Time Frame
30 days after TAVR procedure
Title
The rate of device success
Description
Device success is defined as following:
Technical success (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)
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 <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
1-year all-cause mortality
Description
all-cause mortality
Time Frame
1 year after TAVR procedure
Title
1-year cardiovascular mortality
Description
Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
Time Frame
1 year after TAVR procedure
Title
1-year adverse aortic events
Description
aortic death, aortic dissection, or aortic rupture
Time Frame
1 year after TAVR procedure
Title
Ascending aortic diameter expansion rate ≥3mm/year
Description
Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
Time Frame
1 year after TAVR procedure
Title
Hospitalization (or re-hospitalization)
Description
Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments <24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)
Time Frame
1 year after TAVR procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe aortic stenosis;
Transfemoral access;
Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
Anticipated life expectancy >1 year;
Age ≥ 65 years.
Exclusion Criteria:
Dominant aortic regurgitation,;
A history of SAVR or TAVR;
A history of aortic surgery;
Emergent TAVR.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, MD
Organizational Affiliation
Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33888385
Citation
VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
Results Reference
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Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement
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