Mechanically Optimizing Cardiac Preload in Heart Failure Patients
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedMarch 30, 2023
March 1, 2023
2.8 years
April 5, 2020
March 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pulmonary arterial pressures
Change in the measured mean pulmonary arterial pressure
During partial balloon occlusion
Secondary Outcomes (1)
Change in cardiac output
During partial balloon occlusion
Study Arms (1)
HF patients
Decompensated heart failure patients undergoing right heart catheterization.
Interventions
Eligibility Criteria
Decompensated congestive heart failure patients referred for right heart catheterization.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardioflow Technologies, LLClead
- Saint Thomas Healthcollaborator
Study Sites (1)
Saint Thomas Heart
Nashville, Tennessee, 37205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2020
First Posted
April 8, 2020
Study Start
September 1, 2021
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
March 30, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share