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Compares treatment options for Aortic Stenosis
Official title Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
ClinicalTrials.gov ID: NCT04634240
What this study is testing
- What it's testing
- Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- \- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or...
- \- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is...
- \- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable...
- Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient...
- [AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2]
You likely can't join if
- PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
- Planned PCI of coronary artery lesion(s)
- Planned surgical revascularization of coronary artery lesion(s)
- Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
- Any factor precluding 5-year follow-up
- Prior coronary artery bypass grafting surgery or surgical valve replacement
See the full eligibility criteria
- \- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)
- \- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI
- \- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis...
- Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have:
- [AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2]
- [Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg]
- patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.
- \- Successful transfemoral TAVR, defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular...
- PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
- Planned PCI of coronary artery lesion(s)
- Planned surgical revascularization of coronary artery lesion(s)
- Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
- Any factor precluding 5-year follow-up
- Prior coronary artery bypass grafting surgery or surgical valve replacement
- Severe mitral regurgitation (\> 3+)
- Severe left ventricular dysfunction (LVEF \< 30%)
- Low coronary takeoff (high risk for coronary obstruction)
- Acute myocardial infarction within 90 days
- Stroke or transient ischemic attack within 90 days
- Renal insufficiency (eGFR \< 30 ml/min) and/or renal replacement Rx
- Hemodynamic or respiratory instability
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Phoenix, Arizona, United States
- Palo Alto, California, United States
- Redlands, California, United States
- Santa Barbara, California, United States
- Torrance, California, United States
- Atlantis, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Gainesville, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Elkhart, Indiana, United States
- Fort Wayne, Indiana, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Wichita, Kansas, United States
- Boston, Massachusetts, United States
- Lansing, Michigan, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Phoenix, Arizona, United States; Palo Alto, California, United States; Redlands, California, United States; Santa Barbara, California, United States; Torrance, California, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.