Prognostic Impact of the Evolution of PAH 3 Months After TAVI (HTP-TAVI)
NCT ID: NCT04008550
Last Updated: 2020-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
101 participants
INTERVENTIONAL
2019-03-06
2020-03-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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No Pulmonary Arterial Hypertension before TAVI
No intervention has been done in this group of patients.
No interventions assigned to this group
Pulmonary Arterial Hypertension before TAVI
In this group, a right heart catheterization is done 3 months after TAVI in order to evaluate PAH (persistence or regression).
Right Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
Interventions
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Right Heart Catheterization
A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
Eligibility Criteria
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Inclusion Criteria
* Indication of TAVI
Exclusion Criteria
* Pregnancy
* Persons deprived of their liberty
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Eric Durand, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2018/093/HP
Identifier Type: -
Identifier Source: org_study_id
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