NCT04008550

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Pulmonary Hypertension

Interventions

Type	Name	Description
PROCEDURE	Right Heart Catheterization	A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)

Timeline

• Start date: 2019-03-06
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2019-07-05
• Last updated: 2020-08-05

Locations

1 site across 1 country: France