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

University Hospital, Rouen

Status: Terminated

Conditions: Aortic Valve Stenosis; Pulmonary Hypertension

Treatments: Procedure: Right Heart Catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT04008550

2018/093/HP

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aortic stenosis
• Indication of TAVI

Exclusion criteria

• Contra-indication of right heart catheterization
• Pregnancy
• Persons deprived of their liberty

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

No Pulmonary Arterial Hypertension before TAVI

No Intervention group

Description:

No intervention has been done in this group of patients.

Pulmonary Arterial Hypertension before TAVI

Other group

Description:

In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).

Treatment:

Procedure: Right Heart Catheterization