Active — Not RecruitingNot Applicable

PERIGON Pivotal Trial

United States1,312 participantsStarted 2014-05-12

Plain-language summary

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
✓. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
✓. Patient is of legal age to provide informed consent in the country where they enroll in the trial
✓. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial

Exclusion criteria

✕. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
✕. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
✕. Patient presents with active endocarditis, active myocarditis or other systemic infection
✕. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
✕. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
✕. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2
✕. Patient has hyperparathyroidism
✕. Patient is participating in another investigational device or drug trial or observational competitive study

What they're measuring

Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant

Timeframe: 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year

Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure

Timeframe: Discharge (up to 30 days), 3-6 months, 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant

Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year

Timeframe: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant

Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant

Timeframe: Discharge (up to 30 days), 3-6 months, and 1 year post-implant

Trial details

NCT IDNCT02088554

SponsorMedtronic Cardiac Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-17

Results submitted2024-04-10

View on ClinicalTrials.gov More Aortic Stenosis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
✓. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
✓. Patient is of legal age to provide informed consent in the country where they enroll in the trial
✓. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial

Exclusion criteria

✕. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
✕. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
✕. Patient presents with active endocarditis, active myocarditis or other systemic infection
✕. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
✕. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
✕. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2
✕. Patient has hyperparathyroidism
✕. Patient is participating in another investigational device or drug trial or observational competitive study