NCT03077139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

March 7, 2017

Last Update Submit

September 19, 2017

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

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

    Primary Outcome

    the procedure

Study Arms (1)

Arms

EXPERIMENTAL

Pacing wires used to stimulate ventricles in a synchronous matter

Device: Cardiac Resynchronization Therapy (CRT)

Interventions

Cardiac Resynchronization Therapy (CRT)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.

Arms

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • LVEF \< 50%
  • MWT 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Daniel Morin, MD

    Cardiac Electrophysiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiac Electrophysiologist

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 10, 2017

Study Start

November 29, 2012

Primary Completion

March 23, 2017

Study Completion

March 23, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

US(1)