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 |
|---|---|
| Feops | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.
Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Study design Prospective, observational multi-center trial with 2 cohorts.
Study population
Main Endpoints
1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2. Incidence of > trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots |
| |
| Cohort B | Consecutive patients eligible for TAVI with ACURATE-NEO2 valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEops HEARTguideTM | Other | A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan. |
| Measure | Description | Time Frame |
|---|---|---|
| overall device success conform the VARC-2 document |
| 30 days after TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of more than trivial PVL | total incidence of trivial PVL | 30 days after TAVI |
| conduction abnormalities and need for new permanent pacemaker implantation |
|
Not provided
Inclusion Criteria:
Cohort A:
Cohort B:
Exclusion Criteria:
Not provided
Not provided
Not provided
This prospective multi-center international Registry of TAVI patients include for Cohort A patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid aortic valves, severely calcified aortic valve and small aortic roots.
And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas van Mieghem, MD, PhD | Contact | +31107035260 | n.vanmieghem@erasmusmc.nl | |
| Thijmen Hokken, MD | Contact | +31107038896 | t.hokken@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas van Mieghem, Md,PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | 3015GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23084102 | Background | Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
| 30 days after TAVI |
| D014694 |
| Ventricular Outflow Obstruction |