Aortic Valve Stenosis, Pulmonary Hypertension
Conditions
Keywords
TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization
Brief summary
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI. Currently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death. The hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression). The aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.
Interventions
PROCEDURERight Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
Sponsors
University Hospital, Rouen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aortic stenosis * Indication of TAVI
Exclusion criteria
* Contra-indication of right heart catheterization * Pregnancy * Persons deprived of their liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for heart failure or death any cause (composite endpoint) | Up to 24 months | Time before the first event (hospitalization or death any cause) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative evolution of the PAH, according to the type of pre-operative PAH | Year 2 | PAPm (mean pulmonary arterial pressure) measurement |
| Prevalence of pre-TAVI PAH | Year 0 | In percent and according to the type of PAH (pre-TAVI) |
| Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI) | Year 2 | Occurrence of clinical events |
| Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH | Month 3 | Occurrence of clinical events |
| Concordance between the PAH measurement techniques: echocardiography and right heart catheterization | Month 3 | PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization) |
Countries
France
Outcome results
None listed