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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05052177
Other study ID # University of Bordeaux
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date October 30, 2022

Study information

Verified date September 2021
Source University of Bordeaux
Contact Alexandre SILINI
Phone 0678746867
Email alexandre.silini@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve. It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes .


Description:

Patients with systemic right ventricle (mostly congenitally-corrected transposition of the great arteries or transposition of the great arteries corrected by atrial switch) commonly develop significant systemic tricuspid valve regurgitation which is a therapeutic dilemma for the care team. Surgery (valvuloplasty or replacement) is the common and historical treatment but the rate of mortality is high and results about long-term benefit are contradicting. Percutaneous edge to edge repair could be a alternative to surgery. 10 high-risk surgical patients with severe systemic tricuspid regurgitation undergoing a percutaneous repair were included between January 2019 and November 2022. Our study is a retrospective analysis of short and mid-term clinical, biological, echocardiographic and MRI/TDM outcomes with an expected minimum follow-up of 2 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18-years-old - Right systemic ventricle - Severe tricuspid regurgitation - Symptomatic patient (NYHA 2 - 4) despite optimal medical therapy - High-risk surgical patient deemed not eligible for surgery by a multi-disciplinary and thus having underwent a percutaneous treatment of tricuspid regurgitation Exclusion Criteria: - pregnant - breastfeeding women

Study Design


Intervention

Device:
Edge to edge repair in systemic tricuspid valve regurgitation
Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.

Locations

Country Name City State
France Bordeaux University Hospital Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data. Clinical data : dyspnea (NYHA 1/2/3/4), heart palpitations (yes/no), heart failure in the 6 previous months (yes/no) 2 years
Primary VO2 max testing data. VO2 max testing: VO2 max (ml/min/kg), strenght in watts 2 years
Primary Biological data. Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months 2 years
Primary Echographic data. Echocardiographic data : tricuspid insuffisency severity (régurgitant orifice area in mm²), régurgitant volume (mL)), tricuspid annular diameter (cm), and right ventricle systemic function (S'VD in cm/s, TAPSE in mm, shortening right ventricle fraction in %), and area (end-diastolic and end-systolic area) at baseline, 6, 12, 24 months 2 years
Primary Cross-sectionnal Imaging data. Cross-sectionnal imaging data : quantitative parameters of tricuspid regurgitation (regurgitant volume in mL, percentage of regurgitation in %) and right ventricle systemic function (ejection fraction in %) and volume (end-diastolic and end-systolic volume in mL) at baseline and 6 months. 2 years
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