Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis (EARLY TAVR)
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ClinicalTrials.gov Identifier: NCT03042104 |
Recruitment Status :
Recruiting
First Posted : February 3, 2017
Last Update Posted : September 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Aortic Stenosis Heart Diseases | Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1109 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis |
Actual Study Start Date : | July 12, 2017 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2031 |

Arm | Intervention/treatment |
---|---|
Experimental: TAVR
Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV.
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Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients in experimental arm will receive SAPIEN 3 / SAPIEN 3 Ultra THV.
Other Name: SAPIEN 3, SAPIEN 3 Ultra |
No Intervention: CS
Clinical surveillance
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- Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization. [ Time Frame: 2 years ]For the analysis, the trial arms will be compared using the log-rank test.
- Death or disabling stroke [ Time Frame: 2 years ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Severe aortic stenosis
- Patient is asymptomatic
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Exclusion Criteria:
- Patient is symptomatic.
- Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042104
Contact: Elizabeth Lau, PhD | 949-250-3592 | Elizabeth_Lau@edwards.com | |
Contact: John Tejeda | John_Tejeda@edwards.com |

Principal Investigator: | Philippe Généreux, MD | Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT03042104 |
Other Study ID Numbers: |
2016-07 |
First Posted: | February 3, 2017 Key Record Dates |
Last Update Posted: | September 18, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Stenosis Heart Disease Valve |
Tricuspid Aortic Valve Asymptomatic |
Heart Diseases Aortic Valve Stenosis Constriction, Pathologic Cardiovascular Diseases |
Pathological Conditions, Anatomical Heart Valve Diseases Ventricular Outflow Obstruction |