Trial Outcomes & Findings for Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study) (NCT NCT01051518)

Last Updated: 2019-02-19

Results Overview

Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.

Recruitment status

COMPLETED

Study phase

Target enrollment

126 participants

Primary outcome timeframe

30 (+7) days post procedure

Results posted on

2019-02-19

Participant Flow

Nine sites from Western Europe and Canada enrolled 126 subjects between May 2006 and November 2008.

Of 126 subjects enrolled, 124 were implanted with the CoreValve aortic valve.

Participant milestones

Participant milestones
Measure	Overall Study All enrolled subjects for whom the procedure of percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.
Overall Study STARTED	126
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Risk n=72 Participants Subjects with a high risk of operative mortality.	Moderate Risk n=54 Participants Subjects with a moderate risk of operative mortality.	Total n=126 Participants Total of all reporting groups
Age, Continuous	81.3 years STANDARD_DEVIATION 7.2 • n=5 Participants	83.8 years STANDARD_DEVIATION 4.9 • n=7 Participants	82.4 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	20 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Canada	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Netherlands	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United Kingdom	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Germany	39 Participants n=5 Participants	22 Participants n=7 Participants	61 Participants n=5 Participants
EuroSCORE	28.9 Percent of predicted operative mortality STANDARD_DEVIATION 14.5 • n=5 Participants	16.1 Percent of predicted operative mortality STANDARD_DEVIATION 8.5 • n=7 Participants	23.4 Percent of predicted operative mortality STANDARD_DEVIATION 13.8 • n=5 Participants
NYHA NYHA class I	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
NYHA NYHA class II	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
NYHA NYHA class III	37 Participants n=5 Participants	31 Participants n=7 Participants	68 Participants n=5 Participants
NYHA NYHA class IV	21 Participants n=5 Participants	5 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 (+7) days post procedure

Outcome measures

Outcome measures
Measure	High Risk n=72 Participants Subjects with a high risk of operative mortality.	Moderate Risk n=54 Participants Subjects with a moderate risk of operative mortality.	Overall Study n=126 Participants All enrolled subjects for whom the procedure for percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.
Composite Major Adverse Event (MAE) Free Rate	54.2 Percentage of subjects Interval 42.0 to 66.0	48.1 Percentage of subjects Interval 34.3 to 62.2	51.6 Percentage of subjects Interval 42.5 to 60.6

SECONDARY outcome

Timeframe: Was assessed during the procedure and completed once the procedure was conlcluded

Population: For two patients in the moderate risk group the composite technical device success could not be calculated because not all measurements required were available.

Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction. The four measures of the ''Device Functionality Assessment'' were: * Load the valve delivery system using the loading system * Access the aortic valve with the delivery catheter * Deploy the valve accurately across the native aortic valve * Remove the intact delivery system

Outcome measures

Outcome measures
Measure	High Risk n=72 Participants Subjects with a high risk of operative mortality.	Moderate Risk n=52 Participants Subjects with a moderate risk of operative mortality.	Overall Study n=124 Participants All enrolled subjects for whom the procedure for percutaneous implantation of the Medtronic CoreValve aortic valve prosthesis was started.
Composite Technical Device Success	84.7 Percentage of subjects Interval 74.3 to 92.1	80.8 Percentage of subjects Interval 67.5 to 90.4	83.1 Percentage of subjects Interval 75.3 to 89.2

Adverse Events

High Risk

Serious events: 68 serious events

Other events: 64 other events

Deaths: 47 deaths

Moderate Risk

Serious events: 46 serious events

Other events: 47 other events

Deaths: 20 deaths

Serious adverse events

Other adverse events

Additional Information

M. Hollander

Medtronic

Phone: +31620534428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	High Risk n=72 participants at risk Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.	Moderate Risk n=54 participants at risk Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.
Blood and lymphatic system disorders	12.5% 9/72 • Number of events 11 • Adverse events were reported from date of implantation till 4 years follow up	3.7% 2/54 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up
Cardiac disorders	65.3% 47/72 • Number of events 81 • Adverse events were reported from date of implantation till 4 years follow up	63.0% 34/54 • Number of events 49 • Adverse events were reported from date of implantation till 4 years follow up
Endocrine disorders	2.8% 2/72 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Gastrointestinal disorders	19.4% 14/72 • Number of events 14 • Adverse events were reported from date of implantation till 4 years follow up	11.1% 6/54 • Number of events 8 • Adverse events were reported from date of implantation till 4 years follow up
General disorders	25.0% 18/72 • Number of events 21 • Adverse events were reported from date of implantation till 4 years follow up	16.7% 9/54 • Number of events 10 • Adverse events were reported from date of implantation till 4 years follow up
Infections and infestations	31.9% 23/72 • Number of events 36 • Adverse events were reported from date of implantation till 4 years follow up	16.7% 9/54 • Number of events 11 • Adverse events were reported from date of implantation till 4 years follow up
Injury, poisoning and procedural complications	15.3% 11/72 • Number of events 12 • Adverse events were reported from date of implantation till 4 years follow up	11.1% 6/54 • Number of events 7 • Adverse events were reported from date of implantation till 4 years follow up
Investigations	1.4% 1/72 • Number of events 1 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Metabolism and nutrition disorders	5.6% 4/72 • Number of events 4 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Musculoskeletal and connective tissue disorders	4.2% 3/72 • Number of events 4 • Adverse events were reported from date of implantation till 4 years follow up	5.6% 3/54 • Number of events 3 • Adverse events were reported from date of implantation till 4 years follow up
Neoplasms benign, malignant and unspecified (incl cysts and polyps)	5.6% 4/72 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Nervous system disorders	23.6% 17/72 • Number of events 20 • Adverse events were reported from date of implantation till 4 years follow up	18.5% 10/54 • Number of events 10 • Adverse events were reported from date of implantation till 4 years follow up
Product Issues	4.2% 3/72 • Number of events 3 • Adverse events were reported from date of implantation till 4 years follow up	3.7% 2/54 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up
Psychiatric disorders	2.8% 2/72 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up	3.7% 2/54 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up
Renal and urinary disorders	16.7% 12/72 • Number of events 13 • Adverse events were reported from date of implantation till 4 years follow up	7.4% 4/54 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up
Skin and subcutaneous tissue disorders	1.4% 1/72 • Number of events 1 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Surgical and medical procedures	11.1% 8/72 • Number of events 9 • Adverse events were reported from date of implantation till 4 years follow up	9.3% 5/54 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up
Vascular disorders	18.1% 13/72 • Number of events 14 • Adverse events were reported from date of implantation till 4 years follow up	11.1% 6/54 • Number of events 7 • Adverse events were reported from date of implantation till 4 years follow up

Measure	High Risk n=72 participants at risk Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.	Moderate Risk n=54 participants at risk Overall study population was divided in high and moderate risk groups based on the risk of operative mortality. The risk classification was performed by 2 independent cardiovascular surgeons who were blinded to procedural details and outcomes but were provided with the baseline logistic EuroSCORE, baseline data and available source documentation.
Blood and lymphatic system disorders	23.6% 17/72 • Number of events 19 • Adverse events were reported from date of implantation till 4 years follow up	29.6% 16/54 • Number of events 18 • Adverse events were reported from date of implantation till 4 years follow up
Cardiac disorders	44.4% 32/72 • Number of events 40 • Adverse events were reported from date of implantation till 4 years follow up	35.2% 19/54 • Number of events 29 • Adverse events were reported from date of implantation till 4 years follow up
Congenital, familial and genetic disorders	2.8% 2/72 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up	1.9% 1/54 • Number of events 1 • Adverse events were reported from date of implantation till 4 years follow up
Gastrointestinal disorders	13.9% 10/72 • Number of events 12 • Adverse events were reported from date of implantation till 4 years follow up	13.0% 7/54 • Number of events 8 • Adverse events were reported from date of implantation till 4 years follow up
General disorders	22.2% 16/72 • Number of events 21 • Adverse events were reported from date of implantation till 4 years follow up	20.4% 11/54 • Number of events 15 • Adverse events were reported from date of implantation till 4 years follow up
Infections and infestations	33.3% 24/72 • Number of events 32 • Adverse events were reported from date of implantation till 4 years follow up	38.9% 21/54 • Number of events 26 • Adverse events were reported from date of implantation till 4 years follow up
Injury, poisoning and procedural complications	9.7% 7/72 • Number of events 8 • Adverse events were reported from date of implantation till 4 years follow up	9.3% 5/54 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up
Investigations	8.3% 6/72 • Number of events 6 • Adverse events were reported from date of implantation till 4 years follow up	13.0% 7/54 • Number of events 7 • Adverse events were reported from date of implantation till 4 years follow up
Metabolism and nutrition disorders	4.2% 3/72 • Number of events 3 • Adverse events were reported from date of implantation till 4 years follow up	5.6% 3/54 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up
Musculoskeletal and connective tissue disorders	6.9% 5/72 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up	7.4% 4/54 • Number of events 4 • Adverse events were reported from date of implantation till 4 years follow up
Nervous system disorders	13.9% 10/72 • Number of events 13 • Adverse events were reported from date of implantation till 4 years follow up	16.7% 9/54 • Number of events 14 • Adverse events were reported from date of implantation till 4 years follow up
Psychiatric disorders	2.8% 2/72 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up	11.1% 6/54 • Number of events 6 • Adverse events were reported from date of implantation till 4 years follow up
Renal and urinary disorders	23.6% 17/72 • Number of events 20 • Adverse events were reported from date of implantation till 4 years follow up	13.0% 7/54 • Number of events 7 • Adverse events were reported from date of implantation till 4 years follow up
Reproductive system and breast disorders	2.8% 2/72 • Number of events 2 • Adverse events were reported from date of implantation till 4 years follow up	0.00% 0/54 • Adverse events were reported from date of implantation till 4 years follow up
Respiratory, thoracic and mediastinal disorders	27.8% 20/72 • Number of events 23 • Adverse events were reported from date of implantation till 4 years follow up	22.2% 12/54 • Number of events 18 • Adverse events were reported from date of implantation till 4 years follow up
Skin and subcutaneous tissue disorders	6.9% 5/72 • Number of events 5 • Adverse events were reported from date of implantation till 4 years follow up	1.9% 1/54 • Number of events 1 • Adverse events were reported from date of implantation till 4 years follow up
Surgical and medical procedures	4.2% 3/72 • Number of events 6 • Adverse events were reported from date of implantation till 4 years follow up	1.9% 1/54 • Number of events 1 • Adverse events were reported from date of implantation till 4 years follow up
Vascular disorders	31.9% 23/72 • Number of events 32 • Adverse events were reported from date of implantation till 4 years follow up	22.2% 12/54 • Number of events 15 • Adverse events were reported from date of implantation till 4 years follow up