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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01250327
First received: November 27, 2010
Last updated: September 17, 2013
Last verified: November 2010
  Purpose

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).


Condition Intervention
Dysfunction of the Prosthetic Conduct
Lesions of the Right Ventricular Outflow Tract.
Device: Melody
Device: bare stent
Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 24 months after intervention ] [ Designated as safety issue: Yes ]
  • procedure success rate [ Time Frame: 24 months after intervention ] [ Designated as safety issue: Yes ]
  • Does the patient need to be operated again? [ Time Frame: 24 months after intervention ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: March 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melody
insertion of a pulmonic valved stent
Device: Melody
insertion of a pulmonic valved stent
Other Name: 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 Name: insertion of a bare metal stent
Active Comparator: Surgery
conventional surgery methode.
Procedure: Surgery
conventional surgery methode
Other Name: conventional surgery methode

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
  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250327

Locations
France
Hôpital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Boudjemline Younes, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01250327     History of Changes
Other Study ID Numbers: P080205
Study First Received: November 27, 2010
Last Updated: September 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
right ventricular outflow tract
endovascular valve insertion
economic evaluation
valved stent

ClinicalTrials.gov processed this record on October 20, 2014