Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve

NCT01445171 | Completed Results DMC FDA Device

• 1 other identifier: 2009-01
• Study Type: interventional
• Target: 295
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.

Conditions

Aortic Valve Stenosis With Insufficiency; Aortic Valve Stenosis

Keywords

Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Percent of Early Adverse Events

  Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.

  Events occuring within 30 days of procedure

• Percent of Late Adverse Events

  Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

  Events occurring >= 31 days and up through 5 years post-implant

Other Outcomes (15)

• Number of Subject's With Device Technical Success

  At time of surgery, an average of 3 hours

• Number of Subject's With Procedural Success

  Discharge(an average of 13 days) or 10 days post-implant, whichever comes first

• Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline

  1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Study Arms (1)

Study Valve

OTHER

Subjects act as own control

Device: Aortic Valve Replacement with EDWARDS INTUITY Valve System

Interventions

Aortic Valve Replacement with EDWARDS INTUITY Valve System DEVICE

Aortic Valve bioprosthesis

Study Valve

Eligibility Criteria

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

You may qualify if:

• years or older
• Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
• Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
• Signed and dated the informed consent form prior to investigation procedures;
• Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.

You may not qualify if:

• Pure aortic insufficiency
• Requires emergency surgery
• Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
• Left ventricular ejection fraction of ≤ 25%
• Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
• Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis
• Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
• Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
• Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
• Disease limiting life expectancy to less than 12 months
• Pregnant or lactating
• Currently participating in another drug or device clinical investigation;
• Documented blood diatheses
• Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
• Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (6)

AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna

Vienna, 1090, Austria

Location

Kerchoff Klinik-Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie

Cologne, 50937, Germany

Location

MHH-Medizinische Hoschschule Hannover

Hanover, 30625, Germany

Location

University Leipzig: Herzzentrum Leipzig Gmbh

Leipzig, 04289, Germany

Location

Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich

Munich, 81377, Germany

Location

Related Publications (5)

• Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103.

  PMID: 28453629 RESULT

• Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1.

  PMID: 25218544 RESULT

• Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8.

  PMID: 23058665 RESULT

• Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509.

  PMID: 29912142 RESULT

• Alaklabi AM, Abdul Rab S, Sabbah BN, Maklad AE, Dokollari A, Van den Eynde J, Pompeu Sa M, Arjomandi Rad A, Ahsan MR, Fatehi Hassanabad A. Innovations in Aortic Valve Replacement: A Comprehensive Overview of the Intuity Rapid Deployment Valve. Cardiol Rev. 2026 Jan-Feb 01;34(1):30-39. doi: 10.1097/CRD.0000000000000657. Epub 2024 Feb 9.

  PMID: 38334371 DERIVED

Related Links

• New York Heart Association Classification

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Andrey_Nersesov@edwards.com

949-250-2500

Study Officials

• Prof Axel Haverich

  MHH Hannover

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: October 3, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 1, 2023
• Results First Posted: February 17, 2020

Record last verified: 2023-08

Locations

AU (1); DE (5)