Aortic Valve StenosisNCT02738853

The Medtronic TAVR 2.0 US Clinical Study

A study testing Medtronic Transcatheter Aortic Valve 2.0 Replacement System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 8 sitesUnited States
Study dates: Apr 2016to 15 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Who cannot join

Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
aspirin or heparin (HIT/HITTS) and bivalirudin
ticlopidine and clopidogrel
nitinol (titanium or nickel)
contrast media

Show all 34Show fewer

Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
Untreated clinically significant coronary artery disease requiring revascularization
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min.
Ongoing sepsis, including active endocarditis
Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Gastrointestinal (GI) bleeding that would preclude anticoagulation
Subject refuses a blood transfusion
Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions
Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
Currently participating in an investigational drug or another device study (excluding registries)
Evidence of an acute myocardial infarction ≤30 days before the study procedure
Need for emergency surgery for any reason
Liver failure (Child-Pugh class C)
Subject is pregnant or breast feeding
Pre existing prosthetic heart valve in any position
Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation)
Severe mitral regurgitation
Severe tricuspid regurgitation
Moderate or severe mitral stenosis
Hypertrophic obstructive cardiomyopathy
Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation
Congenital bicuspid or unicuspid valve verified by echocardiography
Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Houston Methodist Hospital
Houston, Texas, 77030
The University of Kansas Hospital
Kansas City, Kansas, 66160
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Yale-New Haven Hospital
New Haven, Connecticut, 06520
NYU / Langone Medical Center
New York, New York, 10016
New York-Presbyterian Hospital / Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Read the detailed description

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Conditions: Aortic Valve Stenosis
Being tested: Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic Transcatheter Aortic Valve 2.0 Replacement SystemDevice
Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

Study groups in NCT02738853
Study group	Role	What they receive
Medtronic Transcatheter Aortic Valve 2.0 Replacement System	Experimental	Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System Receives: Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement System

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause Mortality Rate
Measured: 30 days
Stroke (Disabling) Rate
Measured: 30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Measured: 30 days

Secondary outcomes (10)

Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
1. All-cause mortality >
2. All stroke (disabling and non-disabling) >
3. Life-threatening bleeding >
4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) >
5. Coronary artery obstruction requiring intervention >
6. Major vascular complication >
7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Measured: 30 days
Percentage of Participants With Life Threatening or Disabling Bleeding
Percentage of participants with life threatening or disabling bleeding - VARC-II definitions
Measured: 30 days
Percentage of Participants With Major Vascular Complication
Percentage of participants with major vascular complication - VARC-II definition
Measured: 30 days
Percentage of Participants With Coronary Artery Obstruction
Percentage of participants with coronary artery obstruction - VARC-II definitions
Measured: 30 days
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions
Measured: 30 days
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition
Measured: 30 days
Device Success Rate (VARC II)
Measured: 24 hours to 7 days
Hemodynamic Performance - Aortic Valve Area
Aortic Valve Area (cm2) by transthoracic echocardiogram
Measured: 30 days
Hemodynamic Performance - Mean Gradient
Mean gradient (mmHg) by transthoracic echocardiogram
Measured: 30 days
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
Total prosthetic regurgitation by transthoracic echocardiogram
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201615 Dec 2021

First posted14 Apr 2016 (estimated)
Study startApr 2016
Primary completionNov 2016
Study completion15 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738853
Sponsor's protocol ID: 10233065DOC
Status last verified: Mar 2023
First submitted: 11 Apr 2016
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10.
PubMed 33199247
Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.
PubMed 29348010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Medtronic TAVR 2.0 US Clinical Study
ClinicalTrials.gov ID: NCT02738853
Acronym / sponsor ID: 10233065DOC
Conditions: Aortic Valve Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Nov 2016 (actual)
Study completion: 15 Dec 2021 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 8 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Medtronic Transcatheter Aortic Valve 2.0 Replacement System	Experimental	Device: Medtronic Transcatheter Aortic Valve 2.0 Replacement SystemTreatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram
Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities
Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater
The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.

Key exclusion criteria (34 listed)

Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated:
Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
Untreated clinically significant coronary artery disease requiring revascularization
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic Transcatheter Aortic Valve 2.0 Replacement SystemTreatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.	Device	Medtronic Transcatheter Aortic Valve 2.0 Replacement System

Primary outcome

All-cause Mortality Rate
Time frame: 30 days
Stroke (Disabling) Rate
Time frame: 30 days
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
Time frame: 30 days

10 secondary outcomes

Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
Time frame: 30 days
Percentage of Participants With Life Threatening or Disabling Bleeding
Time frame: 30 days
Percentage of Participants With Major Vascular Complication
Time frame: 30 days
Percentage of Participants With Coronary Artery Obstruction
Time frame: 30 days
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
Time frame: 30 days
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
Time frame: 30 days
Device Success Rate (VARC II)
Time frame: 24 hours to 7 days
Hemodynamic Performance - Aortic Valve Area
Time frame: 30 days
Hemodynamic Performance - Mean Gradient
Time frame: 30 days
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
Time frame: 30 days

Results and safety

Results posted to the registry on 8 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medtronic Transcatheter Aortic Valve 2.0 Replacement System	93	60

Primary outcome: All-cause Mortality Rate

Time frame: 30 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Medtronic Transcatheter Aortic Valve 2.0 Replacement System n = 60
Value	1.7 (0.2 to 11.2)

Primary outcome: Stroke (Disabling) Rate

Time frame: 30 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Medtronic Transcatheter Aortic Valve 2.0 Replacement System n = 60
Value	1.7 (0.2 to 11.4)

Primary outcome: The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram

Time frame: 30 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Medtronic Transcatheter Aortic Valve 2.0 Replacement System n = 58
Value	72.4 (59.1 to 83.3)

Population analysed: Only subjects with transthoracic echo (TTE) could be analyzed.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events 6 months, All Cause Mortality 60 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAVR 2.0	39 of 60 (65%)	38 of 60 (63.3%)	26 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33199247Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovasc Revasc Med. 2021 May;26:12-16. doi: 10.1016/j.carrev.2020.11.007. Epub 2020 Nov 10.
Derived from this study: PubMed 29348010Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL 3rd, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovasc Interv. 2018 Jan 22;11(2):160-168. doi: 10.1016/j.jcin.2017.10.014.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Forrest, MD principal investigator

Yale New Haven Hospital

Mathew Williams, MD principal investigator

NYU Langone Medical Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Transcatheter Aortic Valve 2.0 Replacement System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality Rate (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738853, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.