Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-06-30

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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemodynamic study, cardiac pacing

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.

Group Type EXPERIMENTAL

Resynchronization therapy of right ventricle

Intervention Type PROCEDURE

Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy

Interventions

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Resynchronization therapy of right ventricle

Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No