CompletedNCT01676727Updated Sep 19, 2018Results posted

ADVANCE Direct Aortic Study

An observational study in Aortic Stenosis and Valvular Heart Disease, sponsored by Medtronic Bakken Research Center. Completed at 9 sites in 6 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Medtronic Bakken Research Center · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 100
Ages: 21 Years and older
Sex: All

Study summary

Read the detailed description

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.

Conditions studied

Aortic Stenosis
Valvular Heart Disease

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Keywords

Transcatheter Aortic valve Implantation
Heart Valve Diseases
Cardiovascular Diseases

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 100 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Medtronic Bakken Research Center is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.

Inclusion criteria

Severe symptomatic aortic valve stenosis requiring treatment
Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
21 years of age or older
Patient is willing and able to comply with all protocol-specified follow-up evaluations
The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion criteria

Exclusion Criteria:

Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
Sepsis, including active endocarditis
Recent myocardial infarction (\<30 days)
Left ventricular or atrial thrombus by echocardiography
Uncontrolled atrial fibrillation
Mitral or tricuspid valvular insufficiency (>grade II)
Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Patients with:
1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
2. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or
3. Thoracic aortic aneurysm in the path of delivery system
Bleeding diathesis or coagulopathy
Patient refuses blood transfusion
Estimated life expectancy of less than 12 months unless TAVI is performed
Creatine clearance \<20 mL/min
Active gastritis or peptic ulcer disease
Pregnancy or intent to become pregnant during study follow up
Patient is participating in another trial that may influence the results of this study
-

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 100 participants (actual)
Patient registry: No

Groups and cohorts

CoreValve aortic valve
Implantation of CoreValve aortic valve via direct aortic approach
Device: CoreValve aortic valve

Interventions

DeviceCoreValve aortic valve
Implantation of CoreValve aortic valve via direct aortic approach

What researchers measure

Primary outcomes

All-cause Mortality
Kaplan-Meier estimate of 30-day all-cause mortality.
Time frame: 30 days post-implant

Secondary outcomes

Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The combined safety endpoint is defined as a composite of: * All-cause mortality * All stroke * Life-threatening bleeding * Acute kidney injury-Stage 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) * High degree AV block requiring permanent pacemaker implantation
Time frame: 1, 6 and 12 months

Results

Posted Jul 30, 2018

Participant flow

Participant flow — Overall Study
Milestone	All Enrolled
Started	100
Implanted	92
Completed	68
Not completed	32
Withdrew: Death	18
Withdrew: Withdrawal by subject	6
Withdrew: Screening failure	5
Withdrew: Not willing to attend 1-year visit	2
Withdrew: Valve explanted	1

Outcome measures

PrimaryAll-cause Mortality

Kaplan-Meier estimate of 30-day all-cause mortality.

Time frame:: 30 days post-implant
Reported as:: Number · Percentage of subjects

All-cause Mortality
Percentage of subjects	Implanted Population
All-cause Mortality	4.4 (1.4 to 10.0)

SecondaryKaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

The combined safety endpoint is defined as a composite of: * All-cause mortality * All stroke * Life-threatening bleeding * Acute kidney injury-Stage 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) * High degree AV block requiring permanent pacemaker implantation

Time frame:: 1, 6 and 12 months
Reported as:: Number · Percentage of subjects

Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Percentage of subjects	Implanted Population
1 month	7.6 (3.4 to 14.2)
6 months	17.6 (10.6 to 26.1)
12 months	19.9 (11.7 to 29.6)

Adverse events

Collected over Adverse event data were collected up to 1 year post-implant procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Implanted Population	16/92 (17.4%)	72/92 (78.3%)	68/92 (73.9%)

Most frequent serious events

Showing 9 of 13

Most frequent serious events
Event	Implanted Population
BleedingVascular disorders	24/92
Vascular access site and access-related complicationsInjury, poisoning and procedural complications	15/92
Permanent Pacemaker ImplantationSurgical and medical procedures	13/92
Renal FailureRenal and urinary disorders	12/92
New or worsened conduction disturbances and arrhythmias without pacemaker implantCardiac disorders	11/92
Failure of current therapy for AS requiring hospitalization or worsening congestive heart failureCardiac disorders	10/92
Stroke-TIAVascular disorders	3/92
Sternotomy or thoracotomy related eventSurgical and medical procedures	2/92
Myocardial InfarctionCardiac disorders	1/92

Baseline characteristics

All enrolled population.

Age, Continuous
Age, Continuous(years)	All Enrolled
Mean	81.9 ± 5.9

Sex: Female, Male
Sex: Female, Male(Participants)	All Enrolled
Female	48
Male	52

Region of Enrollment
Region of Enrollment(participants)	All Enrolled
Czech Republic	20
Netherlands	18
United Kingdom	7
Italy	33
France	15
Germany	7

Study locations

9 sites

Nemocnice Podlesi Trinec
Trinec, 739 61, Czechia
Hopital de Rangueil
Toulouse, 31059 CEDEX 9, France
Universitätsklinikum Halle (Saale)
Halle (Saale), 06120, Germany
Azienda spedaliera Spedali Civili Di Brescia
Brescia, 25123, Italy
Azienda spedaliera Niguarda Ca' Granda Milano
Milano, 20162, Italy
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
Medisch centrum Leeuwarden
Leeuwarden, Netherlands
Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital
Brighton, United Kingdom
Royal Brompton & Harefield NHS Trust
London, SW3 6NP, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01676727
Lead sponsor: Medtronic Bakken Research Center
Responsible party: Sponsor
First posted: Aug 31, 2012
Start date: Sep 2012
Primary completion: Apr 2014
Completion: Aug 2015
Results posted: Jul 30, 2018
Last update: Sep 19, 2018

Study contacts

Neil Moat, M.D.

principal investigator · The Royal Brompton Hospital

Giuseppe Bruschi, M.D.

principal investigator · Azienda spedaliera Niguarda Ca' Granda Milano

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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