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

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

Tracking Information

• First Submitted Date: November 27, 2010
• First Posted Date: November 30, 2010
• Last Update Posted Date: October 18, 2017
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 29, 2010): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 29, 2010)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
• Official Title: Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.
• 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).

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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Device: Melody
  insertion of a pulmonic valved stent
  Other Name: insertion of a pulmonic valved stent
• Device: bare stent
  insertion of a bare metal stent
  Other Name: insertion of a bare metal stent
• Procedure: Surgery
  conventional surgery methode
  Other Name: conventional surgery methode

Study Arms

• Experimental: Melody
  insertion of a pulmonic valved stent
  Intervention: Device: Melody
• Active Comparator: Bare stent
  insertion of a bare metal stent
  Intervention: Device: bare stent
• Active Comparator: Surgery
  conventional surgery methode.
  Intervention: Procedure: Surgery

• Publications *: Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piéchaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody ® 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2013): 93
• Original Estimated Enrollment (submitted: November 29, 2010): 180
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01250327
• Other Study ID Numbers: P080205
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Laurent Piazza, Department Clinical Research of developpement
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Ministry of Health, France

Investigators

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

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2017