Aortic-valve Replacement Clinical Trial
— BELIEVEOfficial title:
Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
| Verified date | March 2024 |
| Source | Corcym S.r.l |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | February 25, 2021 |
| Est. primary completion date | June 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU) 2. The subject has signed the informed consent. 3. The subject is at least 18 years of age at the time of implant and consent signature 4. The subject will be available for post-operative follow-up through one year Exclusion Criteria: 1. The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position 2. The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy 3. The subject has any clinical condition precluding the use of CT imaging with contrast 4. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery 5. The subject has active endocarditis, myocarditis, or sepsis 6. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support 7. The subject is already included in another clinical trial that could confound the results of this clinical investigation |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Montreal Heart Institute | Montréal | Quebec |
| Canada | Universite Laval | Québec | Quebec |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| United States | Oakwood Hospital | Dearborn | Michigan |
| United States | St. Vincent Cardiovascular Research Institute | Indianapolis | Indiana |
| United States | Centennial | Nashville | Tennessee |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Missouri Baptist Hospital | Saint Louis | Missouri |
| United States | Maine Medical Center | Scarborough | Maine |
| United States | Washington Adventist Hospital | Takoma Park | Maryland |
| United States | Valley Health | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Corcym S.r.l | LivaNova |
United States, Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant. 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). |
up to 1 year post-implant | |
| Secondary | Reduced Leaflet Motion Through 4D Volume-rendered CT Scan | Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected. 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). |
up to 1 year post-implant | |
| Secondary | Reduction in Leaflet Motion by Relationship to Devices or Procedure | Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant 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). | up to 1 year post-implant | |
| Secondary | Freedom From All-cause Mortality | Number and incidence of subjects free from all-cause mortality | up to 1 year post-implant | |
| Secondary | Freedom From Valve Re-intervention | Number and incidence of subjects free from valve reintervention | up to 1 year post-implant | |
| Secondary | Freedom From Myocardial Infarction | Number and incidence of subjects free from myocardial infarction | up to 1 year post-implant | |
| Secondary | Freedom From Structural Valve Deterioration | Number and incidence of subjects free from structural valve deterioration | up to 1 year post-implant | |
| Secondary | Freedom From Moderate or Severe Valve Regurgitation | Number and incidence of subjects free from moderate or severe valve regurgitation | up to 1 year post-implant | |
| Secondary | Freedom From Valve Endocarditis | Number and incidence of subjects free from valve endocarditis | up to 1 year post-implant | |
| Secondary | Freedom From Valve Thrombosis | Number and incidence of subjects free from valve thrombosis | up to 1 year post-implant | |
| Secondary | Freedom From Thromboembolic Events | Number and incidence of subjects free from thromboembolic events | up to 1 year post-implant | |
| Secondary | Freedom From Hemolysis | Number and incidence of subjects free from hemolysis | up to 1 year post-implant | |
| Secondary | Freedom From Major Bleeding | Number and incidence of subjects free from major bleeding | up to 1 year post-implant | |
| Secondary | New York Heart Association (NYHA) Assessment | Number and incidence of subjects in the different NYHA class at 1 year post-implant. NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
1 year post-implant | |
| Secondary | Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant | |
| Secondary | Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant | |
| Secondary | Effective Orifice Area Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant | |
| Secondary | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant | |
| Secondary | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant | |
| Secondary | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) | up to 1 year post-implant |