Trial Outcomes & Findings for Behavior of Valve Leaflets Following Aortic Valve Implant (NCT NCT03200574)

NCT ID: NCT03200574

Last Updated: 2024-03-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

1 year post-implant

Results posted on

2024-03-06

Participant Flow

88 subjects undergoing AVR with the commercially available Perceval S Valve (Manufacturer Livanova, now transitioned to Corcym), having signed informed consent and willing and able to undergo 4D CT assessments with contrast (or alternatively TEE) were enrolled in the study. The study was forseeing 24 month of enrollment and 1 Year follow-up. The first enrolment occured on on August 12, 2017, and the last enrollment on May 22, 2019 in a total of 10 clinical study sites.

Participant milestones

Participant milestones
Measure	Aortic Valve LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
Overall Study STARTED	88
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Aortic Valve LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
Overall Study Death	4
Overall Study Withdrawal by Subject	8
Overall Study Long-Term need for anticoagulation	1
Overall Study Relocation	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

Behavior of Valve Leaflets Following Aortic Valve Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
Age, Continuous	70.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Reduction in Leaflet Motion	12 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

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).

Outcome measures

Outcome measures
Measure	Aortic Valve n=87 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients n=1 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes	11 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

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).

Outcome measures

Outcome measures
Measure	Aortic Valve n=12 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Reduced Leaflet Motion Through 4D Volume-rendered CT Scan	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

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).

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients n=15 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M n=19 Participants Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L n=26 Participants Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL n=28 Participants Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach n=41 Participants Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach n=47 Participants Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Reduction in Leaflet Motion by Relationship to Devices or Procedure	12 Participants	1 Participants	3 Participants	4 Participants	4 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from all-cause mortality

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From All-cause Mortality	84 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from valve reintervention

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Valve Re-intervention	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from myocardial infarction

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Myocardial Infarction	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from structural valve deterioration

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Structural Valve Deterioration	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from moderate or severe valve regurgitation

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Moderate or Severe Valve Regurgitation	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from valve endocarditis

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Valve Endocarditis	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from valve thrombosis

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Valve Thrombosis	87 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from thromboembolic events

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Thromboembolic Events	82 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from hemolysis

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Hemolysis	88 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Number and incidence of subjects free from major bleeding

Outcome measures

Outcome measures
Measure	Aortic Valve n=88 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Freedom From Major Bleeding	85 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year post-implant

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.

Outcome measures

Outcome measures
Measure	Aortic Valve n=69 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
New York Heart Association (NYHA) Assessment NYHA class I	52 Participants	—	—	—	—	—	—
New York Heart Association (NYHA) Assessment NYHA class II	17 Participants	—	—	—	—	—	—
New York Heart Association (NYHA) Assessment NYHA Class III	0 Participants	—	—	—	—	—	—
New York Heart Association (NYHA) Assessment NYHA class IV	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

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)

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)	22.6 mmHg Standard Deviation 9.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)	12.5 mmHg Standard Deviation 5.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Effective Orifice Area Through Transthoracic Echocardiogram (TTE)	1.7 cm2 Standard Deviation 0.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) No regurgitation	51 Participants	—	—	—	—	—	—
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Trace	4 Participants	—	—	—	—	—	—
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Mild	9 Participants	—	—	—	—	—	—
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Moderate	1 Participants	—	—	—	—	—	—
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Not evaluable	3 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) None	60 Participants	—	—	—	—	—	—
Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Trace	2 Participants	—	—	—	—	—	—
Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Mild	5 Participants	—	—	—	—	—	—
Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Not evaluable	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 1 year post-implant

Outcome measures

Outcome measures
Measure	Aortic Valve n=68 Participants LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Symtomatic Patients LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.	Subjects Implanted With Perceval S Size M Subjects with RLM implanted with Perceval size M	Subjects Implanted With Perceval S Size L Subjects with RLM implanted with Perceval size L	Subjects Implanted With Perceval Size XL Subjects with RLM implanted with Perceval size XL	Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach Subjects with RML implanted with Perceval via minimally invasive surgical approach	Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach Subjects with RLM implanted with Perceval via full sternotomy surgical approach
Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) None	60 Participants	—	—	—	—	—	—
Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Trace	1 Participants	—	—	—	—	—	—
Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Mild	6 Participants	—	—	—	—	—	—
Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) Not evaluable	1 Participants	—	—	—	—	—	—

Adverse Events

Aortic Valve

Serious events: 38 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Aortic Valve n=88 participants at risk LivaNova bioprosthetic aortic heart valve replacement 4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
Injury, poisoning and procedural complications Access site haematoma	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Blood and lymphatic system disorders Bleeding disorders	3.4% 3/88 • Number of events 3 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Blood and lymphatic system disorders Blood disorders	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Arrhythmias and conduction disorders	13.6% 12/88 • Number of events 12 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Cardiac arrest/cardiorespiratory arrest	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Cardiac decompensation	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Heart Failure	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Pericardial effusion	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Thrombosis, Valve	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Gastrointestinal disorders Gastrointestinal and hepatobiliary disorders	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
General disorders Chest pain, noncardiac	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Bacteremia	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Investigations Lab Test abnormality	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Social circumstances Injuries, Trauma, Social circumstances	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Musculoskeletal and connective tissue disorders Fracture	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Confusion, Delirium	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Dizziness / Vertigo	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Numbness	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Other Neurologic Disorder	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Stroke (CVA)	5.7% 5/88 • Number of events 5 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Nervous system disorders Syncope / loss of consciousness	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Renal and urinary disorders Renal failure	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Renal and urinary disorders Other renal and genitourinary disorders	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Dyspnoea/Shortness of breath	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Arterial stenosis	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Embolization (air, tissue, septic, device)	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Peripheral artery stenosis/peripheral vaso-occlusive disease/peripheral vascular disease	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Thrombophlebitis	4.5% 4/88 • Number of events 4 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Thrombosis, deep vein	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Vascular disorders Hypertension	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications Access site infection	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Injury, poisoning and procedural complications Other access site complications	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Cardiac disorders Other cardiac disorder	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
General disorders Death unknown cause	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
General disorders Other general system disorders	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Genitourinary infections	2.3% 2/88 • Number of events 2 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Respiratory system infections	3.4% 3/88 • Number of events 3 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Sepsis	1.1% 1/88 • Number of events 1 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.
Infections and infestations Skin and subcutaneous infections	4.5% 4/88 • Number of events 4 • Overall incidences of Serious Adverse Events reported between implant (day 0) and 1 year follow up The investigators were required to report only SAEs to the Sponsor defined as Adverse event that led to any of the following 1. death, 2. serious deterioration in the health of the subject, users, or other persons 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Other (Not Including Serious) Adverse Events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Elisa Cerutti

Corcym S.r.l.

Phone: +393459182413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place