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

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ClinicalTrials.gov Identifier: NCT01250327
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Dysfunction of the Prosthetic Conduct Lesions of the Right Ventricular Outflow Tract Device: Melody Device: bare stent Procedure: Surgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 24 months after intervention ]
  2. procedure success rate [ Time Frame: 24 months after intervention ]
  3. Does the patient need to be operated again? [ Time Frame: 24 months after intervention ]


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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01250327     History of Changes
Other Study ID Numbers: P080205
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

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