Pressure Volume Loop

NCT04478188 | Unknown DMC

• 1 other identifier: 00000164
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this study and medical record review to measure simultaneous pressure and volume of the heart called pressure volumes loops before and after ventricular assist device placement for cardiogenic shock ( a severe form of heart failure). Standard of care measurements will be the sole measure of clinical determination. The investigators are measuring these PV loops to help determine which patients heart have recovered and can have the ventricular assist device removed. The investigators are also using the PV loop to indicate/correlate with certain outcomes to predict the need for LVAD patients to require additional support in the form of a right ventricular assist device. The medical record review will be performed pre-operatively, intra-operatively, and post-operatively until the day of discharge.

Conditions

Cardiogenic Shock; Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Ventricular Pressure Volume Loop Analysis

  Three Load independent Parameters will be measured and analyzed at three different time points. Pre, post implant and at explant

  Up to 90 days

Secondary Outcomes (1)

• Survival and device explant rate

  1 year

Study Arms (1)

Cardiogenic Shock Patients Needing TMCS

Heart failure patients who undergo TMCS insertion for acute decompensated heart failure and cardiogenic shock.

Other: Measuring Pressure Volume Loop Pre and Post Device Placement

Interventions

Measuring Pressure Volume Loop Pre and Post Device Placement OTHER

To measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal.

Cardiogenic Shock Patients Needing TMCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All cardiogenic shock patients requiring mechanical circulatory support devices can be enrolled in the study. The patients chart will be examined for possible exclusion by the PI or implanting surgeon who is also a co-investigator.

You may qualify if:

• All cardiogenic shock patients requiring temporary mechanical circulatory support (TMCS) (Impella, Tandem heart and ECMO). Age \>=18

You may not qualify if:

• Age \<18, All patients requiring ECRP
• Patients with a Mechanical Aortic Valve
• Patients with Left Ventricular Thrombus

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Danny Ramzy, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Ramzy, MD

CONTACT

310-423-1877; danny.ramzy@cshs.org

Soheila Abbassi, MBA

CONTACT

310-423-5086; soheila.abbassi@cshs.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Robotic Cardiac Surgery, Principal Investigator, Assosiate Professor of Surgery

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2023
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

US (1)