NCT03200574|CompletedResultsDMCFDA Device
Behavior of Valve Leaflets Following Aortic Valve Implant
BELIEVE
Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
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Sponsor study identifier
interventional
88
2 countries
11
Study Start
December 6, 2017
Actual (reported)Primary Completion
June 15, 2020
Actual (reported)Study Completion
February 25, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 25, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2017
Actual (reported)June 27, 2017
Actual (reported)December 6, 2017
Actual (reported)June 15, 2020
Actual (reported)February 25, 2021
Actual (reported)December 26, 2023
Actual (reported)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
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
LivaNova bioprosthetic aortic heart valve replacement
4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46290, United States
Maine Medical Center
Scarborough, Maine, 04074, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Missouri Baptist Hospital
St Louis, Missouri, 63131, United States
Centennial
Nashville, Tennessee, 37203, United States
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.
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.
Niv Ad, MD
Washington Adventist Hospital
Federico Asch, MD
Medstar Health Research Institute
88 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2017
First Posted
June 27, 2017
Study Start
December 6, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Valley Health
Winchester, Virginia, 22601, United States
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Universite Laval
Québec, Quebec, G1V4G5, Canada
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
June 15, 2020
Actual (reported)Study Completion
February 25, 2021
Actual (reported)Last Updated
March 6, 2024
Results First Posted
December 26, 2023
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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