Trial Outcomes & Findings for Optimize PRO Study (NCT NCT04091048)

NCT ID: NCT04091048

Last Updated: 2025-11-13

Results Overview

All-cause mortality or all-stroke at 30 days.

Recruitment status

COMPLETED

Target enrollment

1127 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Main Protocol Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum Evolut™ FX System: Aortic valve replacement
Overall Study STARTED	928	199
Overall Study COMPLETED	653	151
Overall Study NOT COMPLETED	275	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Results of the Main Protocol and FX Addendum are analyzed separately.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 30 days post procedure

Population: The attempted implant set was the basis for the primary outcome measure for the Main Protocol and FX Addendum. The attempted implant set consists of all enrolled subjects with an attempted TAVR implant procedure, defined as when the subject is brought into the procedure room and any of the following have occurred: anesthesia or conscious sedation administered, vascular line placed, TEE placed, or any monitoring line placed. Main Protocol and FX Addendum results are analyzed separately.

All-cause mortality or all-stroke at 30 days.

Outcome measures

Outcome measures
Measure	Main Protocol n=653 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=151 Participants Evolut™ FX System: Aortic valve replacement
All-cause Mortality or All-stroke	5.1 Percent of Participants (K-M Rate)	2.7 Percent of Participants (K-M Rate)

SECONDARY outcome

Timeframe: Through discharge up to 7 days post index procedure.

Population: The basis for the length of stay secondary outcome measure was the per-protocol (PP) set 1 for TAVR care pathway for the Main Protocol and the attempted implant set for the FX Addendum. PP set 1 for TAVR care pathway consists of all implanted subjects with percutaneous and transfemoral access only and no concomitant procedures including percutaneous coronary intervention. Main Protocol and FX Addendum results are analyzed separately.

Median days from index procedure to discharge

Outcome measures

Outcome measures
Measure	Main Protocol n=635 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=149 Participants Evolut™ FX System: Aortic valve replacement
Length of Stay	2.0 Days Interval 1.0 to 31.0	1.0 Days Interval 1.0 to 27.0

SECONDARY outcome

Timeframe: Through discharge up to 7 days post index procedure.

Population: The implanted set was the basis for the AR secondary outcome measure for both the Main Protocol and FX Addendum. The implanted set consists of all the attempted implant subjects who are actually implanted with the Medtronic TAV device. Main Protocol and FX Addendum results are analyzed separately.

Percentage of subjects with ≥ moderate AR at discharge

Outcome measures

Outcome measures
Measure	Main Protocol n=627 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=145 Participants Evolut™ FX System: Aortic valve replacement
Aortic Regurgitation (AR)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The basis for the pacemaker implantation or worsening conduction disturbance secondary outcome measure was the PP set 2 for the Main Protocol and the attempted implant set for the FX Addendum. PP set 2 for conduction disturbance pathway set consists of all attempted implant subjects whose peri- and post-TAVR index procedure follows the conduction disturbance pathway management and cusp overlap technique. Main Protocol and FX Addendum results are analyzed separately.

Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days

Outcome measures

Outcome measures
Measure	Main Protocol n=322 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=151 Participants Evolut™ FX System: Aortic valve replacement
Pacemaker Implantation or Worsening Conduction Disturbance	6.5 Percent of Participants (K-M Rate)	6.7 Percent of Participants (K-M Rate)

SECONDARY outcome

Timeframe: 30 days

Population: The FX Addendum implanted set was the basis for the depth of implant outcome measure. The implanted set consists of all attempted implant subjects who are actually implanted with the Medtronic Evolut™ FX device.

Percentage of subjects with a Non-Coronary Cusp (NCC) depth of implant between 1.0 and 5.0 mm (Evolut FX Addendum Only)

Outcome measures

Outcome measures
Measure	Main Protocol n=136 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum Evolut™ FX System: Aortic valve replacement
Depth of Implant (Evolut FX Only)	83 Participants	—

SECONDARY outcome

Timeframe: 30 Days

Population: The FX Addendum implanted set was the basis for the canting outcome measure. The implanted set consists of all attempted implant subjects who are actually implanted with the Medtronic Evolut™ FX device.

Percentage of subjects with a canting absolute value \[NCC- Left Coronary Cusp(LCC)\] of ≤ 2.0 mm (Evolut FX Addendum Only)

Outcome measures

Outcome measures
Measure	Main Protocol n=135 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum Evolut™ FX System: Aortic valve replacement
Canting (Evolut FX Addendum Only)	59 Participants	—

Adverse Events

Main Protocol

Serious events: 212 serious events

Other events: 0 other events

Deaths: 32 deaths

FX Addendum

Serious events: 44 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Katie Flor, Clinical Research Manager

Medtronic Cardiovascular

Phone: 262 693 6127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Main Protocol n=653 Participants Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=151 Participants Evolut™ FX System: Aortic valve replacement	Total n=804 Participants Total of all reporting groups
Age, Continuous Main Protocol	79.1 years STANDARD_DEVIATION 6.5 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	79.1 years STANDARD_DEVIATION 6.5 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Age, Continuous FX Addendum Cohort	—	78.3 years STANDARD_DEVIATION 7.1 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	78.3 years STANDARD_DEVIATION 7.1 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Sex: Female, Male Main Protocol · Female	307 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	307 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Sex: Female, Male Main Protocol · Male	346 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	346 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Sex: Female, Male FX Addendum · Female	—	67 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	67 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Sex: Female, Male FX Addendum · Male	—	84 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	84 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · American Indian or Alaska Native	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · Asian	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · Black or African American	11 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	11 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · Native Hawaiian or Other Pacific Islander	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	1 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · White	432 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	432 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized Main Protocol · Other	5 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	—	5 Participants n=451 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · American Indian or Alaska Native	—	1 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	1 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · Asian	—	0 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	0 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · Black or African American	—	6 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	6 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · Native Hawaiian or Other Pacific Islander	—	2 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	2 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · White	—	141 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	141 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Race/Ethnicity, Customized FX Addendum · Other	—	1 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.	1 Participants n=151 Participants • Main Protocol: Ethnicity and race are reported only by United States, Canada, Australia and New Zealand (n=451). Not reported for Europe, Middle East, and Africa (EMEA \[n=202\]). Results of the Main Protocol and FX Addendum are analyzed separately.
Body Mass Index (BMI) Main Protocol	29.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately	—	29.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately
Body Mass Index (BMI) FX Addendum	—	30.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately	30.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately
NYHA Main Protocol · NYHA I	0 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	0 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA Main Protocol · NYHA II	374 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	374 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA Main Protocol · NYHA III	256 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	256 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA Main Protocol · NYHA IV	23 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	23 Participants n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA FX Addendum · NYHA I	—	1 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	1 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA FX Addendum · NYHA II	—	110 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	110 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA FX Addendum · NYHA III	—	38 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	38 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
NYHA FX Addendum · NYHA IV	—	2 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	2 Participants n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
STS Score Main Protocol	3.2 Mean STANDARD_DEVIATION 2.5 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	—	3.3 Mean STANDARD_DEVIATION 2.3 • n=653 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.
STS Score FX Addendum	—	3.1 Mean STANDARD_DEVIATION 2.0 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.	3.1 Mean STANDARD_DEVIATION 2.0 • n=151 Participants • Results of the Main Protocol and FX Addendum are analyzed separately.

Serious adverse events
Measure	Main Protocol n=653 participants at risk Evolut™ PRO and Evolut™ PRO+ System: Aortic valve replacement	FX Addendum n=151 participants at risk Evolut™ FX System: Aortic valve replacement
Blood and lymphatic system disorders Anaemia	1.8% 12/653 • Number of events 15 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	1.3% 2/151 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Blood loss anaemia	0.61% 4/653 • Number of events 5 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Iron deficiency anaemia	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Nephrogenic anaemia	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Normocytic anaemia	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Blood and lymphatic system disorders Thrombocytopenia	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Acute left ventricular failure	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	2.0% 3/151 • Number of events 4 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Acute myocardial infarction	2.6% 17/653 • Number of events 20 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Angina pectoris	0.00% 0/653 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Angina unstable	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Aortic valve incompetence	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Arrhythmia	0.61% 4/653 • Number of events 4 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrial fibrillation	4.4% 29/653 • Number of events 34 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	4.6% 7/151 • Number of events 7 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrial flutter	0.61% 4/653 • Number of events 4 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrioventricular block	0.46% 3/653 • Number of events 3 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrioventricular block complete	8.4% 55/653 • Number of events 55 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	6.0% 9/151 • Number of events 10 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrioventricular block first degree	0.92% 6/653 • Number of events 6 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrioventricular block second degree	1.8% 12/653 • Number of events 12 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Atrioventricular dissociation	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Bradyarrhythmia	0.00% 0/653 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Bradycardia	0.61% 4/653 • Number of events 4 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	2.0% 3/151 • Number of events 3 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Bundle branch block	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Bundle branch block left	3.2% 21/653 • Number of events 21 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	2.6% 4/151 • Number of events 4 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiac arrest	1.4% 9/653 • Number of events 9 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	1.3% 2/151 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiac failure	1.2% 8/653 • Number of events 10 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiac failure acute	2.0% 13/653 • Number of events 14 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiac failure congestive	0.77% 5/653 • Number of events 6 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	2.0% 3/151 • Number of events 3 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiac tamponade	0.46% 3/653 • Number of events 3 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiogenic shock	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiomegaly	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Cardiopulmonary failure	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Conduction disorder	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Coronary artery disease	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Coronary artery embolism	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Coronary artery thrombosis	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.66% 1/151 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Defect conduction intraventricular	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Ischaemic cardiomyopathy	0.31% 2/653 • Number of events 2 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Left ventricular dysfunction	0.15% 1/653 • Number of events 1 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\
Cardiac disorders Mitral valve incompetence	0.46% 3/653 • Number of events 3 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\	0.00% 0/151 • Adverse Events collected starting at the time the informed consent was signed until the end of the study (i.e. 12 month follow-up post procedure) or study exit, whichever occurs first. Serious adverse events (SAE), device deficiencies (DD), and non-serious VARC-2 adverse events (that are outlined in the protocol) will be collected from the time of enrollment until the end of the study or until study exit, whichever comes first. Results reported below are through 12-month follow-up post procedure or study exit whichever occurs first. \Note there were no non-serious events by MedDRA preferred term that exceeded the 5% frequency threshold reporting.\