Using CT imaging and computer simulation to improve heart valve replacement outcomes
Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
This study is testing if using CT scans and computer models can help doctors choose the best heart valve size and placement for patients getting a TAVR procedure, to improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 454 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 2 sites (Vienna and 1 other locations) |
| Trial ID | NCT05788770 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining preoperative CT imaging with patient-specific computer modeling to predict outcomes in transcatheter aortic valve replacement (TAVR) procedures. The study utilizes advanced simulation technology (FEops HEARTguide™) to assess how different valve sizes and implantation depths interact with a patient's unique anatomy. By predicting risks such as paravalvular leakage and conduction disorders, the trial aims to determine if this approach can lead to better preoperative decision-making and improved patient outcomes during TAVR. Participants will be randomized to assess the impact of this technology on procedural success.
Who should consider this trial
Good fit: Ideal candidates include individuals with primary symptomatic severe aortic valve stenosis who are accepted for TAVR.
Not a fit: Patients who have previously undergone surgical aortic valve replacement or have a permanent pacemaker may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate preoperative assessments and improved outcomes for patients undergoing TAVR.
How similar studies have performed: While the use of imaging and simulation in TAVR is an emerging field, similar studies have shown promising results in improving procedural outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary symptomatic severe aortic valve stenosis * Accepted for TAVR, either by transfemoral, transsubclavian or transapical access * Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA) * Informed consent Exclusion Criteria:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization: * Previous surgical aortic valve replacement * Permanent pacemaker at baseline * Emergency procedure * Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest * Patient who did not agree to the informed consent and/or refused to participate * Patient unable to understand the informed consent/study
Where this trial is running
Vienna and 1 other locations
- Vienna General Hospital — Vienna, Austria (Recruiting)
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Patrick Klein, MD, PhD — St. Antonius Hospital
- Study coordinator: Romy Hegeman, MD
- Email: r.hegeman@antoniusziekenhuis.nl
- Phone: +31 (0)6 41 71 16 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.