Behavior of Valve Leaflets Following Aortic Valve Implant

NCT03200574 | Completed Results DMC FDA Device

• 1 other identifier: APR002
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 11

Brief Summary

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

Conditions

Aortic-valve Replacement

Keywords

Perceval

Outcome Measures

Primary Outcomes (1)

• Reduction in Leaflet Motion

  Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).

  1 year post-implant

Secondary Outcomes (20)

• Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes

  up to 1 year post-implant

• Reduced Leaflet Motion Through 4D Volume-rendered CT Scan

  up to 1 year post-implant

• Reduction in Leaflet Motion by Relationship to Devices or Procedure

  up to 1 year post-implant

• Freedom From All-cause Mortality

  up to 1 year post-implant

• Freedom From Valve Re-intervention

  up to 1 year post-implant

Study Arms (1)

Aortic Valve

OTHER

LivaNova bioprosthetic aortic heart valve replacement

Diagnostic Test: 4D Cardiac CT Scan; Device: LivaNova Bioprothetic Aortic Valve Implant

Interventions

4D Cardiac CT Scan DIAGNOSTIC_TEST

4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy

Aortic Valve

LivaNova Bioprothetic Aortic Valve Implant DEVICE

Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.

Aortic Valve

Eligibility Criteria

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

You may qualify if:

• The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
• The subject has signed the informed consent.
• The subject is at least 18 years of age at the time of implant and consent signature
• The subject will be available for post-operative follow-up through one year

You may not qualify if:

• The subject has any medical condition requiring long term (\> 6 months) anticoagulation or dual antiplatelet therapy
• The subject has any clinical condition precluding the use of CT imaging with contrast
• The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
• The subject has active endocarditis, myocarditis, or sepsis
• The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
• The subject is already included in another clinical trial that could confound the results of this clinical investigation

Sponsors & Collaborators

• Corcym S.r.l: lead
• LivaNova: collaborator

Study Sites (11)

St. Vincent Cardiovascular Research Institute

Indianapolis, Indiana, 46290, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Oakwood Hospital

Dearborn, Michigan, 48124, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Missouri Baptist Hospital

St Louis, Missouri, 63131, United States

Location

Centennial

Nashville, Tennessee, 37203, United States

Location

Valley Health

Winchester, Virginia, 22601, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Universite Laval

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (10)

• Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 Sep 4;371(10):967-8. doi: 10.1056/NEJMc1408396. No abstract available.

  PMID: 25184874 BACKGROUND

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Mohr FW, Holzhey D, Mollmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Bohm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014 Nov;46(5):808-16. doi: 10.1093/ejcts/ezu290. Epub 2014 Jul 30.

  PMID: 25079769 BACKGROUND

• Laschinger JC, Wu C, Ibrahim NG, Shuren JE. Reduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective. N Engl J Med. 2015 Nov 19;373(21):1996-8. doi: 10.1056/NEJMp1512264. Epub 2015 Oct 5. No abstract available.

  PMID: 26437127 BACKGROUND

• Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

  PMID: 26436963 BACKGROUND

• Beholz S, Repossini A, Livi U, Schepens M, El Gabry M, Matschke K, Trivedi U, Eckel L, Dapunt O, Zamorano JL. The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial. J Heart Valve Dis. 2010 Jan;19(1):115-23.

  PMID: 20329497 BACKGROUND

• Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.

  PMID: 26443880 BACKGROUND

• Grubitzsch H, Wang S, Matschke K, Glauber M, Heimansohn D, Tan E, Francois K, Thalmann M. Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study. Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-104. doi: 10.1093/ejcts/ezu471. Epub 2014 Dec 13.

  PMID: 25501554 BACKGROUND

• Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available.

  PMID: 24603191 BACKGROUND

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 BACKGROUND

Results Point of Contact

• Title: Elisa Cerutti
• Organization: Corcym S.r.l.

elisa.cerutti@corcym.com

+393459182413

Study Officials

• Niv Ad, MD

  Washington Adventist Hospital

  PRINCIPAL INVESTIGATOR

• Federico Asch, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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

Model Details: Prospective, multi-center trial

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 27, 2017
• Study Start: December 6, 2017
• Primary Completion: June 15, 2020
• Study Completion: February 25, 2021
• Last Updated: March 6, 2024
• Results First Posted: December 26, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CA (3)