Clinical trial NCT02023775: Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
Official title: Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Congenital Cardiopathies
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 409
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients receiving a valve implantation, without exception (exhaustive population)

Brief summary: Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.

Detailed description: This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.

Eligibility criteria: Inclusion Criteria:

* Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).

Exclusion Criteria:

* Patient or legal representative refusal to data collection or processing
* Patient unable to guarantee follow-up data collection, in particular for patients living abroad

Primary outcomes:
measure: absence of re-intervention on the pulmonary valve
timeFrame: 12 months
Secondary outcomes:
measure: rate re-intervention on the valve
timeFrame: 60 months
measure: time period before re-intervention on the valve
timeFrame: 60 months
measure: patient characteristics
timeFrame: 60 months
measure: Description and time of onset of open surgery after implantation
timeFrame: 60 months
measure: failures of the implantation procedure
timeFrame: 60 months
measure: survival rate at 12, 36, 48 and 60 months
timeFrame: 60 months
measure: frequency of antiplatelet treatment during and after implant
timeFrame: 60 months
measure: patients' characteristics to indications of the MELODY™ bioprosthesis
timeFrame: 60 months
measure: time period before the resumption of professional, university or scholastic activity
timeFrame: 60 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Le Plessis-Robinson
country: France
facility: Centre chirurgical Marie Lannelongue
city: Lille
country: France
facility: Hôpital Cardiologique
city: Marseille
country: France
facility: Hôpital de La Timone Enfants
city: Nantes
country: France
facility: Hôpital Laënnec
city: Paris
country: France
facility: Hôpital des enfants Malades Necker
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut-Lévêque
city: Toulouse
country: France
facility: Hôpital des enfants Purpan
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Hôpital des enfants Malades - Necker, 149 rue de Sèvres, 75015 Paris, France
name: Sophie MALEKZADEH-MILANI, MD
role: PRINCIPAL_INVESTIGATOR
References: