Trial Outcomes & Findings for Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (NCT NCT02673697)
NCT ID: NCT02673697
Last Updated: 2024-03-06
Results Overview
The primary endpoint is freedom from MACCE (composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) at one year based on Clinical Event Committee (CEC) adjudication.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
914 participants
Primary outcome timeframe
1 year post-operatively
Results posted on
2024-03-06
Participant Flow
A total of 914 patients were enrolled in the PERSIST-AVR trial. Among the 914 patients enrolled, 910 underwent randomization
A total of 914 patients were enrolled in the PERSIST-AVR trial. Among the 914 patients enrolled, 910 underwent randomization. 4 patients were not randomized due to consent withdrawal (2 cases) and physician decision (2 cases)
Participant milestones
| Measure |
Perceval
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
457
|
|
Overall Study
Implanted
|
450
|
446
|
|
Overall Study
Per-Protocol Population
|
407
|
412
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
453
|
457
|
Reasons for withdrawal
| Measure |
Perceval
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
32
|
24
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
7
|
|
Overall Study
Change subj medical status
|
1
|
2
|
|
Overall Study
Explant
|
10
|
5
|
|
Overall Study
Sponsor Decision to stop follow up
|
391
|
416
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Perceval
n=407 Participants
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
n=412 Participants
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
Total
n=819 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 5.6 • n=407 Participants
|
75.0 years
STANDARD_DEVIATION 6.1 • n=412 Participants
|
75.2 years
STANDARD_DEVIATION 5.9 • n=819 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=407 Participants
|
185 Participants
n=412 Participants
|
389 Participants
n=819 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=407 Participants
|
227 Participants
n=412 Participants
|
430 Participants
n=819 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 year post-operativelyPopulation: Per Protocol Population
The primary endpoint is freedom from MACCE (composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) at one year based on Clinical Event Committee (CEC) adjudication.
Outcome measures
| Measure |
Perceval
n=407 Participants
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
n=412 Participants
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
|---|---|---|
|
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
|
0.917 Proportion of participants
Interval 0.888 to 0.942
|
0.920 Proportion of participants
Interval 0.892 to 0.945
|
SECONDARY outcome
Timeframe: Intra-operativePopulation: Safety population (actual treatment)
1. Cross clamp time during index procedure 2. Cardiopulmonary bypass time during index procedure Start time and finish time were collected for operative room time procedure and calculated for each subject. Mean was calculated and reported in the results sections
Outcome measures
| Measure |
Perceval
n=450 Participants
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
n=446 Participants
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
|---|---|---|
|
Surgical Times
Cardiopulmonary bypass time
|
71.0 Minutes
Standard Deviation 34.1
|
87.8 Minutes
Standard Deviation 33.9
|
|
Surgical Times
Cross clamp time
|
48.5 Minutes
Standard Deviation 24.7
|
65.2 Minutes
Standard Deviation 23.6
|
Adverse Events
Perceval
Serious events: 390 serious events
Other events: 0 other events
Deaths: 32 deaths
Other Stented Biological Valves
Serious events: 342 serious events
Other events: 0 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Perceval
n=450 participants at risk
The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
Perceval valve: Sutureless Aortic Biological Valve
|
Other Stented Biological Valves
n=446 participants at risk
The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
other stented biological valve: Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
6/450 • Number of events 7 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
3.4%
15/446 • Number of events 16 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Nervous system disorders
Stroke
|
4.7%
21/450 • Number of events 22 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
3.6%
16/446 • Number of events 16 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Cardiac disorders
Aortic valve re-intervention
|
2.9%
13/450 • Number of events 13 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
1.6%
7/446 • Number of events 7 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.6%
7/450 • Number of events 8 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.90%
4/446 • Number of events 4 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Vascular disorders
Bleeding
|
6.7%
30/450 • Number of events 31 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
8.7%
39/446 • Number of events 44 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.2%
10/450 • Number of events 10 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
2.9%
13/446 • Number of events 15 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Cardiac disorders
Endocarditis
|
2.4%
11/450 • Number of events 14 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
3.4%
15/446 • Number of events 17 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Cardiac disorders
Structural Valve Deterioration
|
0.44%
2/450 • Number of events 3 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.22%
1/446 • Number of events 1 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Cardiac disorders
Valve thrombosis
|
0.44%
2/450 • Number of events 2 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.00%
0/446 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Cardiac disorders
Arrhythmia or conduction disorder
|
22.2%
100/450 • Number of events 102 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
17.0%
76/446 • Number of events 87 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Vascular disorders
Thromboembolic event, non-cerebral
|
0.67%
3/450 • Number of events 3 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.90%
4/446 • Number of events 4 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
11/450 • Number of events 11 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.45%
2/446 • Number of events 2 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Vascular disorders
Major vascular complication
|
0.67%
3/450 • Number of events 3 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
0.67%
3/446 • Number of events 3 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
Vascular disorders
Other cardiovascular SAE
|
8.7%
39/450 • Number of events 43 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
5.8%
26/446 • Number of events 28 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
|
General disorders
Other non-cardiovascular SAE
|
29.3%
132/450 • Number of events 171 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
27.1%
121/446 • Number of events 170 • All serious adverse events were collected from implant to study closure (2 years completed) (July 31, 2020)
The Principal investigator was required to report to the Sponsor: * all serious adverse events (SAE) * all device deficiencies * all Unanticipated Serious Adverse Device Effects (USADE) Incidences of events are here reported for the Safety Population (actual treatment) based on Clinical Event Commitee Adjudication
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place