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Clinical Trials/NCT03077139
NCT03077139
Completed
Not Applicable

Cardiac Resynchronization Therapy in Pulmonary Hypertension

Dr. Daniel P Morin, MD MPH FHRS1 site in 1 country6 target enrollmentNovember 29, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Dr. Daniel P Morin, MD MPH FHRS
Enrollment
6
Locations
1
Primary Endpoint
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2012
End Date
March 23, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Dr. Daniel P Morin, MD MPH FHRS
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Daniel P Morin, MD MPH FHRS

Cardiac Electrophysiologist

Ochsner Health System

Eligibility Criteria

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

Outcomes

Primary Outcomes

15% increase in cardiac output at the optimal VV interval over baseline cardiac output

Time Frame: the procedure

Primary Outcome

Study Sites (1)

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