NCT03799133 is a NA clinical trial of Florence device in Cardiac Failure, sponsored by Critical Perfusion Inc..

Who is sponsoring NCT03799133?

NCT03799133 is sponsored by Critical Perfusion Inc..

What drugs are being tested in NCT03799133?

Interventions in NCT03799133: Florence device.

What condition does NCT03799133 study?

NCT03799133 studies Cardiac Failure, Ventricular Dysfunction, Valvular Heart Disease.

Is NCT03799133 still recruiting?

NCT03799133 is currently completed. Last updated 23 January 2020.

Last reviewed 2020-01-23 · How we verify

NCT03799133

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery

Completed NA Last updated 23 January 2020

What this trial tests

NA trial testing Florence device in Cardiac Failure in 38 participants. Completed in 28 December 2019.

Timeline

26 September 2018

Primary endpoint
28 December 2019

28 December 2019

Quick facts

Lead sponsor	Critical Perfusion Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	38
Start date	26 September 2018
Primary completion	28 December 2019
Estimated completion	28 December 2019
Sites	1 location across Mexico

Drugs / interventions tested

Florence device

Conditions studied

Cardiac Failure — all drugs for Cardiac Failure →
Ventricular Dysfunction — all drugs for Ventricular Dysfunction →
Valvular Heart Disease — all drugs for Valvular Heart Disease →

Sponsor

Critical Perfusion Inc.

Who can join

18 and older, any sex, with Cardiac Failure or Ventricular Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery. Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

ESICM LIVES 2019 : Berlin, Germany. 28 September - 2 October 2019.
· 2019 · cited 8× · PMID 31559498 · DOI 10.1186/s40635-019-0265-y
Gastric reactance as a marker for major perioperative complications in high-risk cardiac surgery patients undergoing cardiopulmonary bypass.
Godinez-Garcia MM, Guillen-Dolores Y, Soto-Mota A, Alvarez R, et al · · 2025 · PMID 41393115 · DOI 10.3389/fmedt.2025.1662981

Verify or expand the search:

Other recruiting trials for Cardiac Failure

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03799133 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Critical Perfusion Inc.
Last refreshed: 23 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03799133.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing