Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)

Study Overview
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Brief Summary
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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.

Official Title
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Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation

Conditions
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Aortic Valve Stenosis, Pulmonary Hypertension

Intervention / Treatment
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* Procedure: Right Heart Catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aortic stenosis Indication of TAVI Exclusion Criteria: Contra-indication of right heart catheterization Pregnancy Persons deprived of their liberty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Pulmonary Arterial Hypertension before TAVI<br>No intervention has been done in this group of patients. | |
| Other: Pulmonary Arterial Hypertension before TAVI<br>In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression). | Procedure: Right Heart Catheterization<br>* A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for heart failure or death any cause (composite endpoint) | Time before the first event (hospitalization or death any cause) | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative evolution of the PAH, according to the type of pre-operative PAH | PAPm (mean pulmonary arterial pressure) measurement | Year 2 | 
| Prevalence of pre-TAVI PAH | In percent and according to the type of PAH (pre-TAVI) | Year 0 | 
| Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI) | Occurrence of clinical events | Year 2 | 
| Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH | Occurrence of clinical events | Month 3 | 
| Concordance between the PAH measurement techniques: echocardiography and right heart catheterization | PAPm (mean pulmonary arterial pressure) measurement (Echocardiography or right heart catheterization) | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI (Transcatheter Aortic Valve Implantation), Aortic Stenosis, Pulmonary Arterial Hypertension, Right Heart Catheterization