Transcatheter Para-Valvular Leak Closures

NCT05117359 | Completed DMC FDA Device

• 1 other identifier: 16.622retro
• Study Type: observational
• Target: 366
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite improvements in available techniques and prostheses, the long-term evolution of patients after transcatheter paravalvular leak closure remains poorly understood. The objective of this study is to evaluate the long-term outcome of patients after transcatheter paravalvular leak closure and to identify factors predictive of survival. The investigators designed a retrospective multicentre observational registry entitled FFPP (e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France, Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic, mitral, tricuspid or pulmonary valves without limit in its delay of performance.Follow-up of at least one year was expected

Conditions

Paravalvular Aortic Regurgitation; Paravalvular Mitral Regurgitation; Cardiac Valve Disease; Cardiac Catheterization

Keywords

paravalvular leak; cardiac catheterization; cardiac valve; transcatheter; percutaneous

Outcome Measures

Primary Outcomes (1)

• death

  death

  2 years

Secondary Outcomes (2)

• surgical valve replacement

  2 years

• technical success

  1 day

Interventions

transcatheter paravalvular leak closure DEVICE

transcatheter paravalvular leak closure on cardiac valve

Eligibility Criteria

• Age: 18 Years - 118 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:

• Seventeen centres from France, Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic, mitral, tricuspid or pulmonary valves without limit in its delay of performance.

You may not qualify if:

• Patients under 18 years of age,

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sebastien Hascoet, MD, PhD

  Centre Chirurgical Marie Lannelongue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 11, 2021
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 1, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share