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Trial record 47 of 282 for:    Best Disease

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

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ClinicalTrials.gov Identifier: NCT01624870
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : July 30, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Aortic Valve Stenosis
Valvular Heart Disease
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Enrolled
Hide Arm/Group Description All subjects who enrolled in the study
Period Title: Overall Study
Started 200 [1]
Completed 173 [2]
Not Completed 27
Reason Not Completed
Death             19
Withdrawal by Subject             1
CoreValve not implanted             6
Lost to follow up             1
[1]
provided informed consent
[2]
Completed 6 month follow up
Arm/Group Title All Enrolled
Hide Arm/Group Description All subjects enrolled in the study
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
All subjects enrolled in the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants
80.2  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
105
  52.5%
Male
95
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
Netherlands 40
Czech Republic 12
Belgium 19
Italy 51
United Kingdom 8
Germany 70
1.Primary Outcome
Title New-onset Class I or II Indication for Permanent Pacemaker Implantation
Hide Description 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.
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available
Arm/Group Title CoreValve Implant Depth ≤6mm CoreValve Implant Depth >6mm
Hide Arm/Group Description:
Enrolled subjects implanted with a CoreValve device at an implant depth of ≤6mm
Enrolled subjects with a CoreVavle device at an implant depth of >6mm
Overall Number of Participants Analyzed 83 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
13.3
(7.0 to 21.5)
21.4
(14.1 to 29.6)
2.Secondary Outcome
Title Combined Safety Endpoint
Hide Description 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.
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All implanted
Arm/Group Title All Implanted
Hide Arm/Group Description:
All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: Percentage of subjects
6.7
Time Frame Adverse event data were collected up to 6 months post-implant procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Implanted
Hide Arm/Group Description All subjects who were implanted with the CoreValve device. All subjects in whom the procedure was attempted were implanted with the CoreVave device.
All-Cause Mortality
All Implanted
Affected / at Risk (%)
Total   17/194 (8.76%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Implanted
Affected / at Risk (%) # Events
Total   113/194 (58.25%)    
Cardiac disorders   
Myocardial Infarction   3/194 (1.55%)  3
Injury, poisoning and procedural complications   
Vascular access site and access-related complications   44/194 (22.68%)  48
Renal and urinary disorders   
Acute Kidney Injury   7/194 (3.61%)  7
Surgical and medical procedures   
Permanent Pacemaker Implantation   50/194 (25.77%)  50
Valve-related dysfunction requiring repeat procedure   5/194 (2.58%)  6
Vascular disorders   
Stroke-TIA   9/194 (4.64%)  9
Bleeding   55/194 (28.35%)  59
Coronary obstruction   1/194 (0.52%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Implanted
Affected / at Risk (%) # Events
Total   151/194 (77.84%)    
General disorders   
Other Adverse Event  [1]  136/194 (70.10%)  364
Injury, poisoning and procedural complications   
Vascular access site and access-related complications   29/194 (14.95%)  29
Renal and urinary disorders   
Renal Failure   7/194 (3.61%)  7
Surgical and medical procedures   
Permanent Pacemaker Implantation   7/194 (3.61%)  7
Re-intervention   1/194 (0.52%)  1
Vascular disorders   
Stroke-TIA   3/194 (1.55%)  3
Bleeding Event   31/194 (15.98%)  32
Indicates events were collected by systematic assessment
[1]
Any other reported adverse event not associated with the use of the study device were collected without a specific adverse event term.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Maarten Hollander
Organization: Medtronic Bakken Research Center
Phone: +31620534428
Responsible Party: Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier: NCT01624870     History of Changes
Other Study ID Numbers: Advance-II
First Submitted: June 19, 2012
First Posted: June 21, 2012
Results First Submitted: September 6, 2016
Results First Posted: July 30, 2018
Last Update Posted: September 19, 2018