Mechanically Optimizing Cardiac Preload in Heart Failure... | NCT04338503

Studies
Mechanically Optimizing Cardiac Preload in Heart Failure Patients

NCT04338503

Sponsor

Cardioflow Technologies, LLC

Status

Unknown status

Last Update Posted

Mar 30, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Heart Failure

Interventions

Partial IVC occlusion

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Apr 5, 2020

First Submission Date that Met QC Criteria

Apr 5, 2020

First Posted Date

Apr 8, 2020Actual

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

Mar 28, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
Saint Thomas Health	OTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HF patients		Decompensated heart failure patients undergoing right heart catheterization.	Diagnostic Test: Partial IVC occlusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Partial IVC occlusion	Diagnostic Test	Partial balloon occlusion of the inferior vena cava.	HF patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pulmonary arterial pressures	Change in the measured mean pulmonary arterial pressure	During partial balloon occlusion

Secondary Outcomes

Measure	Description	Time Frame
Change in cardiac output	Change in cardiac output measured in liters per minute	During partial balloon occlusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
New York Heart Association (NYHA) II or III.
Subjects must be last least 18 years of age.
A left ventricular ejection fraction >= 20%.
Pulmonary artery occlusion pressure, or pulmonary wedge pressure >20 mmHg.

Exclusion Criteria:

Subjects without sinus rhythm.
Evidence of right heart failure.
Patients with primary pulmonary hypertension
Pulmonary wedge pressure <15mmHg.
Significant lung disease, such as prior diagnosis of COPD.
Resting or dynamic outflow tract gradient
Patients with left bundle branch block

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Decompensated congestive heart failure patients referred for right heart catheterization.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel W Kaiser, MD	Contact	6154152586		dan@cardioflowtech.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas Heart	Recruiting	Nashville	Tennessee	37205	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D011654	Pulmonary Edema

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided