Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-10-31

Brief Summary

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To identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes.

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Detailed Description

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Pure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC), was first described in 1984, has good results and is performed by antegrade access to the mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there have been studies showing excellent results following PMC in all grades of PH, nonregression of PH following PMC is not uncommon. The component of PAP contributed by the passive transmission of the elevated LA pressure regresses immediately after a successful PMC proportional to the reduction in transmitral gradient. The PH contributed by pulmonary arteriolar constriction slowly comes down over weeks or a few months, But a "fixed" component due to pulmonary vascular disease usually persists.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

percutaneous mitral commissurotomy

Study Groups

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Patients with persistent pulmonary hypertension

Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy

Group Type ACTIVE_COMPARATOR

Percutaneous Mitral Commissurotomy

Intervention Type PROCEDURE

Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area \> 1.5 square cm with less than moderate to severe mitral regurgitation.

Patients without persistent pulmonary hypertension

Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy

Group Type ACTIVE_COMPARATOR

Percutaneous Mitral Commissurotomy

Intervention Type PROCEDURE

Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area \> 1.5 square cm with less than moderate to severe mitral regurgitation.

Interventions

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Percutaneous Mitral Commissurotomy

Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area \> 1.5 square cm with less than moderate to severe mitral regurgitation.

Intervention Type PROCEDURE

Other Intervention Names

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Percutaneous mitral valvuloplasty

Eligibility Criteria

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Inclusion Criteria

* Severe mitral stenosis (mitral valve area ≤1.5cm).
* Significant dyspnea.
* Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography

Exclusion Criteria

* Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification.
* Presence of other lesions which need open heart surgery.
* Wilkins' score \> 12.
* Persistent LA thrombus despite adequate anticoagulation.
* End stage renal or liver disease.
* Patients with severe COPD and other chest problems that might be complicated by pulmonary hypertension per se.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No