Trial Outcomes & Findings for PARTNER II Trial: S3iCAP (NCT NCT02687035)

NCT ID: NCT02687035

Last Updated: 2021-04-08

Results Overview

Number of deaths

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1822 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-04-08

Participant Flow

Recruitment took place from January 2015 to August 2016. Subjects in this trial were entered into the TVT Registry. Of the 1822 subjects enrolled in the trial, 1814 subjects received the study device.

Participants that did not receive an Edwards device were not followed in the trial.

Participant milestones

Measure	SAPIEN 3 Patients at intermediate surgical risk receiving the SAPIEN S3 valve with Commander or Certitude delivery system.
Overall Study STARTED	1822
Overall Study COMPLETED	1638
Overall Study NOT COMPLETED	184

Reasons for withdrawal

Measure	SAPIEN 3 Patients at intermediate surgical risk receiving the SAPIEN S3 valve with Commander or Certitude delivery system.
Overall Study Withdrawal by Subject	1
Overall Study Death	87
Overall Study Lost to Follow-up	1
Overall Study Missed Visit	87
Overall Study Did not receive Study Device	8

Baseline Characteristics

PARTNER II Trial: S3iCAP

Baseline characteristics by cohort

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving the SAPIEN S3 valve with Commander or Certitude delivery system.
Age, Continuous	80.7 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	786 Participants n=5 Participants
Sex: Female, Male Male	1028 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	67 Participants n=5 Participants
Race (NIH/OMB) White	1705 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants
Society of Thoracic Surgeons (STS) Score	4.4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants
New York Heart Association (NYHA) Class NYHA I	0 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA II	682 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA III	1041 Participants n=5 Participants
New York Heart Association (NYHA) Class NYHA IV	90 Participants n=5 Participants
New York Heart Association (NYHA) Class Not Assessed	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of deaths

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Death	12 Participants

PRIMARY outcome

Timeframe: 1 year

Number of deaths

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Death	87 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants with stroke

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Stroke	40 Participants

PRIMARY outcome

Timeframe: 1 year

Number of participants with stroke

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Stroke	63 Participants

PRIMARY outcome

Timeframe: 30 days

Number of participants with aortic valve reintervention

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Aortic Valve Reintervention	3 Participants

PRIMARY outcome

Timeframe: 1 year

Number of participants with aortic valve reintervention

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Aortic Valve Reintervention	11 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with annular dissection

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Annular Dissection	1 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with aortic dissection

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Aortic Dissection	5 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with major vascular complications

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Major Access Vascular Site Complication	20 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with unplanned vascular surgery or intervention

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Unplanned Vascular Surgery or Intervention	51 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with retroperitoneal bleed

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Retroperitoneal Bleeds	6 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with gastrointestinal bleeding

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Gastrointestinal Bleed	2 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with genitourinary bleeding

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Genitourinary Bleed	12 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with bleeding at the access site

Outcome measures

Measure	SAPIEN 3 n=1814 Participants Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Bleeding at Access Site	32 Participants

Adverse Events

SAPIEN 3

Serious events: 818 serious events

Other events: 0 other events

Deaths: 87 deaths

Serious adverse events

Measure	SAPIEN 3 n=1814 participants at risk Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.
Cardiac disorders Conduction/native pacer disturbance requiring pacemaker	12.1% 219/1814 • Number of events 220 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Non-valve Related Readmission	19.5% 354/1814 • Number of events 458 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Unplanned Vascular Surgery or Intervention	2.9% 53/1814 • Number of events 54 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Nervous system disorders Ischemic Stroke	2.7% 49/1814 • Number of events 50 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Perforation with or w/o Tamponade	1.4% 25/1814 • Number of events 25 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Injury, poisoning and procedural complications Major Vascular Complication	1.1% 20/1814 • Number of events 20 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Unplanned Other Cardiac Surgery or Intervention	1.6% 29/1814 • Number of events 31 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Cardiac disorders Cardiac Arrest	0.88% 16/1814 • Number of events 16 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Percutaneous Coronary Intervention	1.2% 22/1814 • Number of events 22 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Cardiac disorders Myocardial Infarction	0.94% 17/1814 • Number of events 18 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Cardiac disorders Conduction/native pacer disturbance requiring Implantable Cardioverter Defibrillator	0.72% 13/1814 • Number of events 13 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Major Bleeding Event	1.8% 32/1814 • Number of events 33 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Retroperitoneal Bleeding	0.33% 6/1814 • Number of events 6 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Aortic Dissection	0.28% 5/1814 • Number of events 5 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Valve Related Readmission	0.83% 15/1814 • Number of events 16 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Cardiac disorders Coronary Compression or Obstruction	0.11% 2/1814 • Number of events 2 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Life Threatening Bleeding	0.44% 8/1814 • Number of events 8 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Nervous system disorders Undetermined Stroke	0.22% 4/1814 • Number of events 4 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures New Requirement for Dialysis	0.17% 3/1814 • Number of events 3 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Nervous system disorders Hemorrhagic Stroke	0.28% 5/1814 • Number of events 5 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Annular Dissection	0.06% 1/1814 • Number of events 1 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Vascular disorders Device Embolization Left Ventricle	0.06% 1/1814 • Number of events 1 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Surgical and medical procedures Aortic Valve Re-intervention	0.33% 6/1814 • Number of events 6 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.
Infections and infestations Endocarditis	0.28% 5/1814 • Number of events 5 • All events are reported at 1 year. This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.

Other adverse events

Adverse event data not reported

Additional Information

Edwards THV Clinical Affairs

Edwards Lifesciences

Phone: 949-250-2500

Email: THV_CT.gov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place