Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis: FinnValve Registry

NCT03385915 | Completed DMC

• 1 other identifier: T309/2017
• Study Type: observational
• Target: 6,463
• Locations: 1 country
• Sites: 1

Brief Summary

The FinnValve investigators planned a nationwide registry to investigate the early and late outcome of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) in patients with aortic valve stenosis performed from 2008 to 2017 at five Finnish University Hospitals. Data will be collected in a dedicated electronic case report form.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacement; Transcatheter aortic valve implantation; TAVI; TAVR; Aortic valve replacement; Surgical aortic valve replacement; Sutureless

Outcome Measures

Primary Outcomes (1)

• Death

  All-cause death

  From the index procedure till the end of the follow-up period (December 2017)

Secondary Outcomes (26)

• Atrial fibrillation

  During the index hospital stay, an average of 7 days

• Permanent pace-maker implantation

  From the index procedure till the end of the follow-up period (December 2017)

• Stroke

  From the index procedure till the end of the follow-up period (December 2017)

• Infection

  During the index hospital stay, an average of 7 days

• Acute kidney injury

  During the index hospital stay, an average of 7 days

Study Arms (2)

TAVI cohort

Patients who underwent transcatheter aortic valve implantation for aortic valve stenosis

Procedure: Aortic valve replacement

SAVR cohort

Patients who underwentsurgical aortic valve replacement for aortic valve stenosis

Procedure: Aortic valve replacement

Interventions

Aortic valve replacement PROCEDURE

Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis

SAVR cohort; TAVI cohort

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 who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis at five Finnish University Hospitals from January 2008 to September 2017

You may qualify if:

• Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis
• Patients aged \>18 years
• Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation.
• TAVI and SAVR with or without associated coronary revascularization
• TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage.

You may not qualify if:

• Patients who underwent any prior SAVR or TAVI
• Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta.
• Patients operated on for aortic valve endocarditis
• Patients operated for isolated aortic valve regurgitation.

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator

Study Sites (1)

Heart Center, Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (8)

• Jalava MP, Savontaus M, Ahvenvaara T, Laakso T, Virtanen M, Niemela M, Tauriainen T, Maaranen P, Husso A, Kinnunen E, Dahlbacka S, Jaakkola J, Rosato S, D'Errigo P, Laine M, Makikallio T, Raivio P, Eskola M, Valtola A, Juvonen T, Biancari F, Airaksinen J, Anttila V. Transcatheter and surgical aortic valve replacement in patients with left ventricular dysfunction. J Cardiothorac Surg. 2022 Dec 18;17(1):322. doi: 10.1186/s13019-022-02061-9.

  PMID: 36529781 DERIVED

• Husso A, Airaksinen J, Juvonen T, Laine M, Dahlbacka S, Virtanen M, Niemela M, Makikallio T, Savontaus M, Eskola M, Raivio P, Valtola A, Biancari F. Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve. Clin Res Cardiol. 2021 Mar;110(3):429-439. doi: 10.1007/s00392-020-01761-3. Epub 2020 Oct 24.

  PMID: 33099681 DERIVED

• Laakso T, Laine M, Moriyama N, Dahlbacka S, Airaksinen J, Virtanen M, Husso A, Tauriainen T, Niemela M, Makikallio T, Valtola A, Eskola M, Juvonen T, Biancari F, Raivio P. Impact of paravalvular regurgitation on the mid-term outcome after transcatheter and surgical aortic valve replacement. Eur J Cardiothorac Surg. 2020 Dec 1;58(6):1145-1152. doi: 10.1093/ejcts/ezaa254.

  PMID: 33057657 DERIVED

• Virtanen MPO, Eskola M, Savontaus M, Juvonen T, Niemela M, Laakso T, Husso A, Jalava MP, Tauriainen T, Ahvenvaara T, Maaranen P, Kinnunen EM, Dahlbacka S, Laine M, Makikallio T, Valtola A, Raivio P, Rosato S, D'Errigo P, Vento A, Airaksinen J, Biancari F. Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis. J Cardiothorac Surg. 2020 Jun 29;15(1):157. doi: 10.1186/s13019-020-01203-1.

  PMID: 32600369 DERIVED

• Biancari F, Dahlbacka S, Juvonen T, Virtanen MPO, Maaranen P, Jaakkola J, Laakso T, Niemela M, Tauriainen T, Vento A, Husso A, Savontaus M, Laine M, Makikallio T, Raivio P, Eskola M, Rosato S, Anttila V, Airaksinen J, Valtola A. Favorable outcome of cancer patients undergoing transcatheter aortic valve replacement. Int J Cardiol. 2020 Sep 15;315:86-89. doi: 10.1016/j.ijcard.2020.03.038. Epub 2020 Mar 18.

  PMID: 32216975 DERIVED

• Virtanen MPO, Airaksinen J, Niemela M, Laakso T, Husso A, Jalava MP, Tauriainen T, Maaranen P, Kinnunen EM, Dahlbacka S, Rosato S, Savontaus M, Juvonen T, Laine M, Makikallio T, Valtola A, Raivio P, Eskola M, Biancari F. Comparison of Survival of Transfemoral Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Risk Patients Without Coronary Artery Disease. Am J Cardiol. 2020 Feb 15;125(4):589-596. doi: 10.1016/j.amjcard.2019.11.002. Epub 2019 Nov 19.

  PMID: 31831151 DERIVED

• Moriyama N, Laakso T, Biancari F, Raivio P, Jalava MP, Jaakkola J, Dahlbacka S, Kinnunen EM, Juvonen T, Husso A, Niemela M, Ahvenvaara T, Tauriainen T, Virtanen M, Maaranen P, Eskola M, Rosato S, Makikallio T, Savontaus M, Valtola A, Anttila V, Airaksinen J, Laine M. Prosthetic valve endocarditis after transcatheter or surgical aortic valve replacement with a bioprosthesis: results from the FinnValve Registry. EuroIntervention. 2019 Aug 9;15(6):e500-e507. doi: 10.4244/EIJ-D-19-00247.

  PMID: 31113766 DERIVED

• Makikallio T, Jalava MP, Husso A, Virtanen M, Laakso T, Ahvenvaara T, Tauriainen T, Maaranen P, Kinnunen EM, Dahlbacka S, Jaakkola J, Airaksinen J, Anttila V, Savontaus M, Laine M, Juvonen T, Valtola A, Raivio P, Eskola M, Niemela M, Biancari F. Ten-year experience with transcatheter and surgical aortic valve replacement in Finland. Ann Med. 2019 May-Jun;51(3-4):270-279. doi: 10.1080/07853890.2019.1614657. Epub 2019 May 21.

  PMID: 31112060 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: December 1, 2017
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FI (1)