Post-dilatation after a balloon-expandable TAVI valve
Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses
We will test whether doing a brief extra balloon inflation right after a balloon-expandable TAVI helps adults 65 and older with severe aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07477002 on ClinicalTrials.gov |
What this trial studies
This is a single-center, single-blinded, randomized trial at the Medical University of Vienna that assigns patients 1:1 to routine post-dilatation using the original delivery balloon at nominal volume versus no post-dilatation after valve deployment. In the post-dilatation arm the balloon is reinserted into the deployed transcatheter heart valve and briefly inflated during rapid ventricular pacing to optimize expansion and symmetry. The trial will use imaging (fluoroscopy and CT) and hemodynamic measurements to compare valve expansion, function, and markers of durability, and will track clinical outcomes. Consecutive adults with severe degenerative aortic stenosis who are eligible for transfemoral balloon-expandable TAVI and provide consent are enrolled.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older with severe degenerative aortic stenosis who are planned for transfemoral implantation of a balloon-expandable transcatheter heart valve and can give informed consent.
Not a fit: Patients with bicuspid valves, valve-in-valve procedures, active endocarditis, severe annular calcification risking rupture, significant proximal left coronary stenosis, or who receive non–balloon-expandable valves are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, routine post-dilatation could improve valve expansion and hemodynamics, potentially reducing bioprosthetic valve dysfunction and related complications.
How similar studies have performed: Observational imaging and registry data suggest post-dilatation can improve valve expansion and hemodynamics, but randomized controlled evidence on routine use is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe AS * AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board * Anatomical feasibility to receive a balloon-expandable THV * Age 65 years or older * Informed consent Exclusion Criteria: * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated) * Bicuspid aortic valve anatomy * Valve-in-valve procedure * Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture * Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Christian Nitsche, MD, PhD
- Email: christian.nitsche@meduniwien.ac.at
- Phone: +43-1-40400-48590
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.