Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
Not provided
Not provided
Not provided
Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.
The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEops HEARTGuide | Experimental | Device selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography. |
|
| Standard transcatheter aortic valve implantation (no FEops HEARTGuide) | No Intervention | Control: standard of care, CT based device selection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEops HEARTGuide | Other | FEops HEARTGuide added to routine preoperative CT imaging. Results of the computer modelling will be discussed with TAVR implanting team prior to and during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Mild to severe paravalvular regurgitation | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block) | 30 days after TAVI | |
| Need for permanent pacemaker implantation | 30 days after TAVI | |
Not provided
Inclusion Criteria:
Exclusion Criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romy Hegeman, MD | Contact | +31 (0)6 41 71 16 79 | r.hegeman@antoniusziekenhuis.nl | |
| Dirk-Jan van Ginkel, MD | Contact | +31 (0) 88 320 66 48 | d.van.ginkel@antoniusziekenhuis.nl |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Klein, MD, PhD | St. Antonius Hospital | Principal Investigator |
| Martin Swaans, MD, PhD | St. Antonius Hospital | Principal Investigator |
| Prof. Jurriën ten Berg, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna General Hospital | Recruiting | Vienna | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Multicenter, multinational, randomized controlled, open-label, trial
Not provided
Not provided
Not provided
Not provided
| Preoperative valve size selection |
| Preprocedural |
| Final valve size | Perprocedural |
| Target implantation depth | Preprocedural |
| Final implantation depth | Perprocedural |
| Change of preoperative decision in choice of default transcather heart valve | Preprocedural |
| Change of preoperative decision in valve size selection | Preprocedural |
| Change of preoperative decision in target implantation depth | Preprocedural |
| Failure to implant valve | Preprocedural |
| Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) | Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria | 30 days after TAVI |
| Quality of life assessed by the EuroQol questionnaire | EuroQol-5 Dimensions-5 Levels, lower levels refer to better outcomes. Visual analog scale (0-100). Higher scores refer to a better outcome. | 90 days after TAVI |
| Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire | All scores are represented on a 0-to-100-point scale. Higher score refers to preferabel outcomes. | 90 days after TAVI |
| St. Antonius Hospital |
| Principal Investigator |
| St. Antonius Hospital | Recruiting | Nieuwegein | Utrecht | 3435 CM | Netherlands |
|
| D014694 |
| Ventricular Outflow Obstruction |