Trial Outcomes & Findings for CoreValve Advance-II Study: Prospective International Post-market Study (NCT NCT01624870)

Last Updated: 2018-09-19

Results Overview

The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or \>6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2018-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled All subjects who enrolled in the study
Overall Study STARTED	200
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled All subjects who enrolled in the study
Overall Study Death	19
Overall Study Withdrawal by Subject	1
Overall Study CoreValve not implanted	6
Overall Study Lost to follow up	1

Baseline Characteristics

CoreValve Advance-II Study: Prospective International Post-market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled n=200 Participants All subjects enrolled in the study
Age, Continuous	80.2 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Region of Enrollment Netherlands	40 participants n=5 Participants
Region of Enrollment Czech Republic	12 participants n=5 Participants
Region of Enrollment Belgium	19 participants n=5 Participants
Region of Enrollment Italy	51 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants
Region of Enrollment Germany	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Population: the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available

Outcome measures

Outcome measures
Measure	CoreValve Implant Depth ≤6mm n=83 Participants Enrolled subjects implanted with a CoreValve device at an implant depth of ≤6mm	CoreValve Implant Depth >6mm n=109 Participants Enrolled subjects with a CoreVavle device at an implant depth of \>6mm
New-onset Class I or II Indication for Permanent Pacemaker Implantation	13.3 Percentage of subjects Interval 7.0 to 21.5	21.4 Percentage of subjects Interval 14.1 to 29.6

SECONDARY outcome

Timeframe: 30 days post procedure

Population: All implanted

The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.

Outcome measures

Outcome measures
Measure	CoreValve Implant Depth ≤6mm n=194 Participants Enrolled subjects implanted with a CoreValve device at an implant depth of ≤6mm	CoreValve Implant Depth >6mm Enrolled subjects with a CoreVavle device at an implant depth of \>6mm
Combined Safety Endpoint	6.7 Percentage of subjects	—

Adverse Events

All Implanted

Serious events: 113 serious events

Other events: 151 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	All Implanted n=194 participants at risk All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
Surgical and medical procedures Permanent Pacemaker Implantation	25.8% 50/194 • Number of events 50 • Adverse event data were collected up to 6 months post-implant procedure.
Vascular disorders Stroke-TIA	4.6% 9/194 • Number of events 9 • Adverse event data were collected up to 6 months post-implant procedure.
Vascular disorders Bleeding	28.4% 55/194 • Number of events 59 • Adverse event data were collected up to 6 months post-implant procedure.
Renal and urinary disorders Acute Kidney Injury	3.6% 7/194 • Number of events 7 • Adverse event data were collected up to 6 months post-implant procedure.
Cardiac disorders Myocardial Infarction	1.5% 3/194 • Number of events 3 • Adverse event data were collected up to 6 months post-implant procedure.
Vascular disorders Coronary obstruction	0.52% 1/194 • Number of events 1 • Adverse event data were collected up to 6 months post-implant procedure.
Injury, poisoning and procedural complications Vascular access site and access-related complications	22.7% 44/194 • Number of events 48 • Adverse event data were collected up to 6 months post-implant procedure.
Surgical and medical procedures Valve-related dysfunction requiring repeat procedure	2.6% 5/194 • Number of events 6 • Adverse event data were collected up to 6 months post-implant procedure.

Other adverse events

Other adverse events
Measure	All Implanted n=194 participants at risk All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
Vascular disorders Stroke-TIA	1.5% 3/194 • Number of events 3 • Adverse event data were collected up to 6 months post-implant procedure.
Renal and urinary disorders Renal Failure	3.6% 7/194 • Number of events 7 • Adverse event data were collected up to 6 months post-implant procedure.
Vascular disorders Bleeding Event	16.0% 31/194 • Number of events 32 • Adverse event data were collected up to 6 months post-implant procedure.
Surgical and medical procedures Permanent Pacemaker Implantation	3.6% 7/194 • Number of events 7 • Adverse event data were collected up to 6 months post-implant procedure.
Surgical and medical procedures Re-intervention	0.52% 1/194 • Number of events 1 • Adverse event data were collected up to 6 months post-implant procedure.
Injury, poisoning and procedural complications Vascular access site and access-related complications	14.9% 29/194 • Number of events 29 • Adverse event data were collected up to 6 months post-implant procedure.
General disorders Other Adverse Event	70.1% 136/194 • Number of events 364 • Adverse event data were collected up to 6 months post-implant procedure.

Additional Information

Maarten Hollander

Medtronic Bakken Research Center

Phone: +31620534428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60