Cardiac Resynchronization Therapy in Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Device: Cardiac Resynchronization Therapy (CRT)

• Registration Number: NCT03077139
• Lead Sponsor: Dr. Daniel P Morin, MD MPH FHRS

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-11-29
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Primary Completion: 2017-03-23
• Study Completion: 2017-03-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arms	Cardiac Resynchronization Therapy (CRT)	Pacing wires used to stimulate ventricles in a synchronous matter

Primary Outcome Measures

Name	Time	Method
15% increase in cardiac output at the optimal VV interval over baseline cardiac output	the procedure	Primary Outcome

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States