NCT01876420

Brief Summary

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

June 5, 2013

Results QC Date

September 30, 2016

Last Update Submit

August 21, 2018

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

  • All-cause Mortality Rate at 30 Days

    The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically: Cardiovascular mortality (Any of the following criteria) * Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure) * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease * All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure * All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events * Sudden or unwitnessed death * Death of unknown cause Non-cardiovascular mortality * Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)

    30 days

  • Stroke Rate (Disabling and Non-disabling) at 30 Days

    The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.

    30 days

  • Device Success Rate at 24 Hours to Seven Days

    1. Device success rate at 24 hours to seven days, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \< 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation. 2. The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days).

    24 hours to seven days

Secondary Outcomes (6)

  • VARC II Combined Safety Endpoint at 30 Days

    30 days

  • Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days

    30 days

  • Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient

    30 days

  • Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)

    30 days

  • Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)

    30 days

  • +1 more secondary outcomes

Study Arms (1)

The CoreValve™ Evolut R TAV™ system

EXPERIMENTAL

CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System

Device: The CoreValve™ Evolut R TAV™ system

Interventions

The CoreValve™ Evolut R TAV™ systemDEVICE

CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System

Also known as: CoreValve™ EvolutR™ Transcatheter Ao Valve, EnveoR™ Delivery Catheter System w/ Enveo InLine™ Sheath, EnVeoR™ Loding System
The CoreValve™ Evolut R TAV™ system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Estimated 30 day mortality risk of \> 15% by study center Heart Team assessment,33 OR at least two cardiovascular surgeons from the study center deny surgery because of prohibitive operative risk, estimated to be a combined \>50% risk of irreversible mortality or morbidity.
  • Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
  • The subject meets the legal minimum age to provide informed consent based on local regulatory requirements, and has provided written informed consent as approved by the EC/IRB of the respective clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

You may not qualify if:

  • Subject has been offered SAVR but has declined.
  • Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
  • Known hypersensitivity or contraindication to Nitinol.
  • 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 of creatinine clearance \< 20 cc/min.
  • Ongoing sepsis, including active endocarditis.
  • Any condition considered a contraindication to extracorporeal assistance.
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal stent performed within 30 days prior to Heart Team assessment, or within six months prior to Heart Team assessment for procedures with a drug eluting stents.
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Epworth Hospital

Melbourne, Victoria, 3004, Australia

Location

Monash Medical Center

Melbourne, Victoria, Australia

Location

Waikato Hospital

Hamilton, New Zealand

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

Related Publications (1)

  • Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.

    PMID: 26315740DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Terry Noel
Organization
Medtronic
763-526-0309

Study Officials

  • Eric Vang, PhD

    Director Clinical Research Structural Heart

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 12, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2016

Last Updated

August 22, 2018

Results First Posted

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)NZ(1)AU(2)