Cardiac Resynchronization Therapy in Pulmonary Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- 15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arms
Pacing wires used to stimulate ventricles in a synchronous matter
Intervention: Cardiac Resynchronization Therapy (CRT) (Device)
Outcomes
Primary Outcomes
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Time Frame: the procedure
Primary Outcome
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Daniel P Morin, MD MPH FHRS
Cardiac Electrophysiologist
Ochsner Health System