Actively Recruiting
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Led by Helios Health Institute GmbH · Updated on 2024-11-25
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Helios Health Institute GmbH
Lead Sponsor
H
Heart Center Leipzig - University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the complete coronary physiology in patients with severe symptomatic aortic valve stenosis who are candidates for transcatheter aortic valve implantation (TAVI). The study focuses on those with intermediate coronary artery stenosis and aims to assess how TAVI affects coronary blood flow and microcirculatory function over a six-month period. The study also seeks to compare invasive functional tests with non-invasive CT-based assessments before and after TAVI. Participants will undergo assessments including fractional flow reserve (FFR), resting full cycle ratio (RFR), coronary flow reserve (CFR), index of microvascular resistance (IMR), and computed tomography fractional flow reserve (CT-FFR). These tests will be performed before TAVI and repeated six months following the procedure to evaluate changes in coronary physiology and to correlate invasive and non-invasive testing results. During the study, participants will have coronary CT angiography and invasive coronary angiography with functional measurements. Researchers will compare the values of CFR, IMR, FFR, and RFR before and six months after TAVI. They will also assess diagnostic accuracy using specific thresholds for FFR and RFR values. The study involves regular evaluations over a six-month follow-up period to monitor changes in coronary function after TAVI.
CONDITIONS
Brief Title
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Willing and able to understand, read, and sign informed consent before the planned procedure
- Severe symptomatic aortic stenosis with indication for TAVI as determined by the Heart Team
- Underwent coronary CT angiography before TAVI where coronary artery disease could not be ruled out
- Presence of coronary artery disease with intermediate stenosis (typically 40-90% diameter) in one or more native major vessels or branches
- Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR, IMR)
- Eligible for coronary CT angiography and functional assessment (CT-FFR)
You will not qualify if you...
- Non-diagnostic or unreadable coronary CT angiography
- Previous coronary artery bypass grafting with patent grafts to the vessel studied
- Severe lesions with diameter stenosis equal to or greater than 90%, flow-limiting lesions, or significant left main coronary artery stenosis
- Critical coronary artery disease needing immediate revascularization
- Contraindication to adenosine, such as bronchial asthma
- Severe chronic renal impairment with eGFR less than 30 ml/min
- Presence of cardiogenic shock
- Participation in another interventional study involving the left heart or coronary arteries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day of TAVI procedure
Participants undergo invasive coronary angiography and complete coronary physiology assessment before TAVI, including measurements of CFR, IMR, FFR, and RFR, as well as coronary CT angiography to assess coronary artery stenosis.
1 to 2 visits depending on assessment timing
Duration - Single procedure day
Participants undergo transcatheter aortic valve implantation (TAVI) to treat severe symptomatic aortic valve stenosis.
1 visit (in-person procedure)
Duration - 1 day at 6 months post-TAVI
Six months after TAVI, participants undergo repeat coronary physiology assessment including CFR, IMR, FFR, and RFR measurements to compare with baseline values.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Leipzig, Germany, 04289
Actively Recruiting
Research Team
N
Nicolas Majunke, Dr.
M
Mohamed Abdel-Wahab, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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