Cardiac Resynchronization Therapy in Pulmonary Hypertension | NCT03077139

Studies
Cardiac Resynchronization Therapy in Pulmonary Hypertension

NCT03077139

Sponsor

Dr. Daniel P Morin, MD MPH FHRS

Status

Completed

Last Update Posted

Sep 20, 2017Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Pulmonary Hypertension

Interventions

Cardiac Resynchronization Therapy (CRT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2012Actual

Primary Completion Date

Mar 23, 2017Actual

Completion Date

Mar 23, 2017Actual

First Submitted Date

Mar 7, 2017

First Submission Date that Met QC Criteria

Mar 9, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2017

Last Update Posted Date

Sep 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Ochsner Health SystemSponsor-Investigator

Lead Sponsor

Dr. Daniel P Morin, MD MPH FHRSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arms	Experimental	Pacing wires used to stimulate ventricles in a synchronous matter	Device: Cardiac Resynchronization Therapy (CRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
15% increase in cardiac output at the optimal VV interval over baseline cardiac output	Primary Outcome	the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
Hypertrophic obstructive cardiomyopathy
Amyloidosis
Dependence on pacing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Morin, MD	Cardiac Electrophysiologist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner Medical Center		New Orleans	Louisiana	70121	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058406	Cardiac Resynchronization Therapy

Ancestor Terms

ID	Term
D002304	Cardiac Pacing, Artificial
D004599	Electric Stimulation Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided