Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
NCT06377449
Aneurysm, Aneurysm, Ascending Aorta
Saint Petersburg, Sankt-Peterburg, Russia
View Trial DetailsNCT Number: NCT07578129
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is:
Does the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline.
Participants undergoing tricuspid repair and fulfilling all inclusion/exclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment up to 12 months post-procedure
The GDMT score is calculated by adding all scores of each HF therapy. The minimum score corresponds to no medication taken and is 0. The maximum score is 11 and corresponds to all medications taken at the maximum dose. An intermediate score would be all medications taken at the intermediate dose and would be 6 (ACEi/ARB/ARNI = 2, BB = 2, MRA at 50-99% = 2). A low score would be ACEi/ARB/ARNI, BB and MRA at low dose and would be 3.
The dose of diuretics, although not included in the GDMT score, should be collected and considered separately.
Time frame: From enrollment up to 12 months
Number of hospitalizations related to heart failure at 12 months divided by the number of patients
Time frame: From enrollment up to 12 months
Number of hospitalisations for all cause at 12 months divided by the number of patients
Time frame: At enrollment and at 12 months
Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP
Time frame: At enrollment and at baseline
Comparison of the NYHA class at 12 months with the NYHA class at baseline
Time frame: At enrollment and at 12 months
Comparison of the KCCQ score at 12 months with the KCCQ score at baseline
Contact information is provided by the study sponsor or research team.
Basile Gravez, PhD
CONTACT
Christophe LE ROUX, MSc
CONTACT
Ceric Sàrl
Industry
Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function
Acronym: PASCAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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