The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve

NCT02713932 | Unknown DMC

• 1 other identifier: 84/2010/VE
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a prospective Italian registry including several centers performing TAVI, collecting baseline, procedural and outcome data.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Transcatheter Aortic Valve Replacement

Keywords

Aortic valve stenosis; Aortic valve regurgitation; Transcatheter aortic valve implantation

Outcome Measures

Primary Outcomes (1)

• Major adverse events

  Up to 24 months

Study Arms (1)

Transcatheter aortic valve implantation

Device: Transcatheter aortic valve implantation

Interventions

Transcatheter aortic valve implantation DEVICE

Transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in whom transcatheter aortic valve implantation is attempted at participating center.

You may qualify if:

• Patients in whom transcatheter aortic valve implantation is attempted at participating center.

You may not qualify if:

• None except failure to obtain informed consent.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Related Publications (2)

• Navarese EP, Zhang Z, Kubica J, Andreotti F, Farinaccio A, Bartorelli AL, Bedogni F, Rupji M, Tomai F, Giordano A, Reimers B, Spaccarotella C, Wilczek K, Stepinska J, Witkowski A, Grygier M, Kukulski T, Wanha W, Wojakowski W, Lesiak M, Dudek D, Zembala MO, Berti S; a Joint Effort of the Italian and Polish Cardiac Interventional Societies. Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1196-1206. doi: 10.1016/j.jcin.2021.03.024.

  PMID: 34112454 DERIVED

• Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL, Reimers B, Spaccarotella C, Trani C, Attisano T, Marella Cenname A, Sardella G, Bonmassari R, Medda M, Tomai F, Tarantini G, Navarese EP; Italian Society of Interventional Cardiology-GISEdagger. Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24.

  PMID: 33103545 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Luca Testa, MD

CONTACT

02 527741; luctes@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 21, 2016
• Study Start: July 1, 2010
• Primary Completion: July 1, 2017
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

IT (1)