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

October 16, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melody
insertion of a pulmonic valved stent
Device: Melody
insertion of a pulmonic valved stent
Other Names:
  • insertion of a pulmonic valved stent
Active Comparator: Bare stent
insertion of a bare metal stent
Device: bare stent
insertion of a bare metal stent
Other Names:
  • insertion of a bare metal stent
Active Comparator: Surgery
conventional surgery methode.
Procedure: Surgery
conventional surgery methode
Other Names:
  • conventional surgery methode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.
Time Frame: 24 months after intervention
24 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 24 months after intervention
24 months after intervention
procedure success rate
Time Frame: 24 months after intervention
24 months after intervention
Does the patient need to be operated again?
Time Frame: 24 months after intervention
24 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Boudjemline Younes, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 27, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P080205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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