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Cardiac Resynchronization Therapy in Pulmonary Hypertension

Cardiac Resynchronization Therapy in Pulmonary Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077139
Acronym
CRT in PH
Enrollment
6
Registered
2017-03-10
Start date
2012-11-29
Completion date
2017-03-23
Last updated
2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

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

Sponsors

Dr. Daniel P Morin, MD MPH FHRS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
15% increase in cardiac output at the optimal VV interval over baseline cardiac outputthe procedurePrimary Outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026