Transcatheter Para-Valvular Leak Closure: An International Prospective Multicentre Registry

NCT05089136 | Unknown DMC FDA Device

• 1 other identifier: 16.622
• Study Type: observational
• Target: 213
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prosthetic paravalvular leaks (PVL) leading to heart failure and/or haemolysis can be treated by interventional cardiology or open-heart surgery. Predictors of clinical success of transcatheter closure remains little known and should be identified to help choose between these two options.Patient selection criteria for the best option are needed. The investigators aimed to identify predictors of clinical success after transcatheter PVL closure. Consecutive patients referred to 24 European centres for transcatheter PVL closure in 2017-2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP) and followed over 2 years

Conditions

Valvular Heart Disease; Valve Disease, Heart

Keywords

cardiac valve; cardiac catheterization; paravalvular leak

Outcome Measures

Primary Outcomes (1)

• Death or secondary valve replacement

  Rate of death or secondary valve replacement (transcatheter or surgical replacement)

  2 years

Secondary Outcomes (2)

• Hospitalization for heart failure

  2 years

• Hemolysis

  2 years

Interventions

transcatheter paravalvular leak closure DEVICE

Transcatheter paravalvular leak closure (PVLc) was first described in 1992 and has since then emerged as an attractive alternative to repeat surgery. Many implantable devices that can be used for transcatheter PVLc have been marketed, although few are specifically designed for this purpose. It consist in implanting an occluder in the paravalvular leak to stop or reduce the regurgitant flow.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An electronic case-report form (eCRF, Easy-crf.com) was completed for each patient. The medical history (notably regarding heart surgery), symptoms, physical findings, laboratory test results, and echocardiographic parameters were collected. The EUROSCORE II risk score (http://euroscore.org) was determined, since surgical valve replacement was among the treatment options. Creatinine clearance below 60 mL/min defined renal failure and below 30 mL/min severe renal failure. Heart failure was defined according to the European Society of Cardiology as the presence of symptoms (dyspnoea, orthopnoea, asthenia) with physical signs of heart failure (limb oedema, hepato-jugular reflux, crackles on pulmonary auscultation) linked to the valvular disease. Anaemia was defined as haemoglobin \<13 g/dL in men and \<12 g/dL in women and haemolytic anaemia as anaemia with lactic dehydrogenase elevation and/or schistocytes and/or low haptoglobin, in the absence of other causes of anaemia.

You may qualify if:

• All centres included consecutive patients referred for PVLc. Patients were selected for transcatheter PVLc as opposed to first-line surgical PVLc if they were at high or prohibitive surgical risk or as an alternative option to surgery if transcatheter PVLc feasibility was high. Patients were selected by each heart-team of participating centre according to local practice.

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Related Publications (1)

• Hascoet S, Smolka G, Blanchard D, Kloeckner M, Brochet E, Bouisset F, Leurent G, Thambo JB, Combes N, Dumonteil N, Bauer F, Nejjari M, Pilliere R, Dauphin C, Bonnet G, Ciobotaru V, Ketelers R, Gallet R, Hammoudi N, Mangin L, Bouvaist H, Spaulding C, Aminian A, Kilic T, Popovic B, Armero S, Champagnac D, Gerardin B. Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry. Circ Cardiovasc Interv. 2022 Oct;15(10):e012193. doi: 10.1161/CIRCINTERVENTIONS.122.012193. Epub 2022 Oct 18.

  PMID: 36256693 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Benoit Gerardin

  Hopital Marie Lannelongue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share