Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival. Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.

Official Title
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Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Procedure: Resynchronization therapy of right ventricle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pulmonary hypertension type I, III, IV, V Dana Point classification NYHA classification equal or superior to stage II During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2 Optimal therapy considered by the referring specialist practioner of the patient Exclusion Criteria: Minor or incapacitated adult Pregnancy Unability to give free and informed consent Pulmonary hypertension type II Dana Point classification Eisenmenger syndrome Patent foramen ovale Left bundle-brach block Pulmonary hypertension exacerbation Medical clinical situation considered inappropriate by the investigator Patient eligible for a heart-lung transplant Patient eligible for pulmonary endarterectomy Patient with poor echogenicity Filter in the inferior vena cava

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodynamic study, cardiac pacing<br>We propose to study the hemodynamic response to a temporary atrio-dual right ventricular stimulation in pulmonary arterial hypertension subjects.Patients will be is own comparator. | Procedure: Resynchronization therapy of right ventricle<br>* Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index measured during right catheterization |  | After two minutes of right stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary arterial hypertension, cardiac resynchronization therapy