Clinical trial NCT01445171: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Official title: Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis With Insufficiency
Aortic Valve Stenosis
Keywords: Aortic Valve Replacement
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.

Eligibility criteria: Criteria:

Inclusion Criteria:

* 18 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.

Exclusion Criteria:

* 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
* Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
* Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
* Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
* Documented hyperparathyroidism

Primary outcomes:
measure: Percent of Early Adverse Events
timeFrame: Events occuring within 30 days of procedure
measure: Percent of Late Adverse Events
timeFrame: Events occurring >= 31 days and up through 5 years post-implant
Secondary outcomes:
Other outcomes:
measure: Number of Subject's With Device Technical Success
timeFrame: At time of surgery, an average of 3 hours
measure: Number of Subject's With Procedural Success
timeFrame: Discharge(an average of 13 days) or 10 days post-implant, whichever comes first
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
timeFrame: 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
timeFrame: Baseline, 3 Months, and 1 Year post-implant
measure: Subject's Average Mean Systolic Gradient Measurements Over Time.
timeFrame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Effective Orifice Area Measurements Over Time.
timeFrame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Amount of Aortic Valvular Regurgitation Over Time
timeFrame: Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average White Blood Cell Count Measurement Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Red Blood Cells Count Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Hemoglobin Count Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Hematocrit Percentage Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Platelet Count Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Reticulocytes Percentage Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Haptoglobin Measurement Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
measure: Subject's Average Serum LDH Measurement Over Time.
timeFrame: Baseline, 3 Months, 1 Year, and 5 Years post-implant
Locations:
city: Vienna
country: Austria
facility: AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna
city: Bad Nauheim
country: Germany
facility: Kerchoff Klinik-Bad Nauheim
city: Hannover
country: Germany
facility: MHH-Medizinische Hoschschule Hannover
city: Koeln
country: Germany
facility: Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie
city: Leipzig
country: Germany
facility: University Leipzig: Herzzentrum Leipzig Gmbh
city: Munich
country: Germany
facility: Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich
Study officials:
affiliation: MHH Hannover
name: Prof Axel Haverich
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.