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Cardiac Resynchronization Therapy in Pulmonary Hypertension

NCT ID: NCT03077139

Last Updated: 2017-09-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-29

Study Completion Date

2017-03-23

Brief Summary

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This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.

Detailed Description

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This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.

Conditions

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Pulmonary 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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Arms

Pacing wires used to stimulate ventricles in a synchronous matter

Group Type EXPERIMENTAL

Cardiac Resynchronization Therapy (CRT)

Intervention Type DEVICE

A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.

Interventions

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Cardiac Resynchronization Therapy (CRT)

A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
* LVEF ≥ 50%
* Baseline 6MWT distant \<400 meters
* Baseline NYHA Functional class ≥ III

Exclusion Criteria

* LVEF \< 50%
* 6MWT duration \> 400 meters
* NYHA Functional class \< III
* Left bundle branch block
* Non-sinus rhythm
* Severe aortic stenosis (Aortic valve area \< 1 cm2)
* Severe mitral regurgitation
* Acute cardiac failure
* Dependency on intravenous inotropies
* Severe obstructive pulmonary disease
* Hypertrophic obstructive cardiomyopathy
* Amyloidosis
* Dependence on pacing
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Daniel P Morin, MD MPH FHRS

OTHER

Sponsor Role lead

Responsible Party

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Dr. Daniel P Morin, MD MPH FHRS

Cardiac Electrophysiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel Morin, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Electrophysiologist

Locations

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Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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CRT in PH

Identifier Type: -

Identifier Source: org_study_id