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Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)

NCT ID: NCT01250327

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-08-31

Brief Summary

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This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

Detailed Description

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Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.

Main objective : evaluate the cost of the procedure as compared with conventional technique.

Design : multicenter intervention prospective study. Population : 180 patients in three arms (3\*60).

End point criteria :

* Primary : cost
* Secondary : rate of reoperation

Conditions

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Dysfunction of the Prosthetic Conduct Lesions of the Right Ventricular Outflow Tract

Keywords

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right ventricular outflow tract endovascular valve insertion economic evaluation valved stent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Melody

insertion of a pulmonic valved stent

Group Type EXPERIMENTAL

Melody

Intervention Type DEVICE

insertion of a pulmonic valved stent

Bare stent

insertion of a bare metal stent

Group Type ACTIVE_COMPARATOR

bare stent

Intervention Type DEVICE

insertion of a bare metal stent

Surgery

conventional surgery methode.

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

conventional surgery methode

Interventions

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Melody

insertion of a pulmonic valved stent

Intervention Type DEVICE

bare stent

insertion of a bare metal stent

Intervention Type DEVICE

Surgery

conventional surgery methode

Intervention Type PROCEDURE

Other Intervention Names

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insertion of a pulmonic valved stent insertion of a bare metal stent conventional surgery methode

Eligibility Criteria

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Inclusion Criteria

for the study:

* Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation

for the Melody arm:

* A 5 to 70 years old patient
* Weight \>= 30kg
* RVOT \<= to 22mm
* Patient with a dysfunction circumferential prosthetic conduct of diameter \>= to 16mm.

Exclusion Criteria

* Vein anatomy incompatibility with a 22Fr delivery health
* Left heart implantation
* RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
* Coronary anomaly with a coronary artery naer the RVOT
* Sever obstruction of the RVOT incompatible with balloon expansion
* Central vein obstruction
* Ongoing infection
* Active endocarditis
* Allergy for heparin or aspirin
* Pregnancy
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boudjemline Younes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Necker Enfants Malades

Paris, , France

Site Status

Countries

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France

References

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Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.

Reference Type DERIVED
PMID: 25453718 (View on PubMed)

Other Identifiers

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P080205

Identifier Type: -

Identifier Source: org_study_id