Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA
New heart valve procedure may be streamlined with CT scans
Plain English Summary
The EASE-IT CT Registry is a Not Applicable clinical trial sponsored by Institut für Pharmakologie und Präventive Medizin studying Transcatheter Aortic Valve Implantation (TAVI). This study compares two ways to check for heart artery blockages before a valve replacement procedure. It's for older adults (75+) who need a transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. Participants will either have a CT scan only or a CT scan plus a standard invasive test. The alternative is the current standard of care, which involves more invasive testing. The trial aims to enroll 150 participants.
Official Summary
ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 75 or older and scheduled for a TAVI procedure. You cannot join if you have already been diagnosed with significant blockages in major heart arteries or have had previous heart procedures. Your life expectancy must be at least 12 months. This trial is studying Transcatheter Aortic Valve Implantation (TAVI), so participants generally need a confirmed diagnosis.
What They're Measuring
The study will track how many patients experience heart artery-related problems within 3 months after the TAVI procedure, to ensure the CT-only approach is safe. The specific primary outcome measures are: Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI (30 days); Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI (3 months); Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria (30 days); Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria (30 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to see if a less invasive CT scan can safely replace a more invasive procedure for checking heart arteries before a TAVI, potentially making the process quicker and safer for patients. This research targets Transcatheter Aortic Valve Implantation (TAVI), where improved treatment options are needed.
Investor Insight
This trial explores a more efficient pre-procedure pathway for TAVI, a growing market, potentially reducing costs and improving patient throughput.
Is This Trial Right for Me?
Ask your doctor if a CT scan alone is sufficient for your pre-TAVI assessment. Participation involves undergoing either a CT scan only or a CT scan followed by a standard invasive test. You will have follow-up appointments at 30 days and 3 months after your procedure. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 150 participants
Interventions
- OTHER: Streamlining of the pre-procedural patient pathway — Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.
Primary Outcomes
- Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI (30 days)
- Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI (3 months)
- Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria (30 days)
- Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria (30 days)
Full Eligibility Criteria
Inclusion Criteria: Investigational CTA-only Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family * Ability to undergo CTA * Patient is scheduled to undergo a 30 Day and 3 Months follow-up CTA+ICA control Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis * Ability to undergo CTA and ICA Exclusion Criteria: investigational CTA-only Cohort * Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement CTA+ICA control Cohort * Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement
Trial Locations
- Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie, Innsbruck, Tyrol, Austria
- University Clinic St. Pölten, Sankt Pölten, Austria
- Medical University of Vienna, Vienna, Austria
- Klinik Floridsdorf, Vienna, Austria
- University Hospital Bochum / HDZ NRW, Bad Oeynhausen, North Rhine-Westphalia, Germany
- University Hospital of the Bergmannsheil gGmbH, Bochum, North Rhine-Westphalia, Germany
Frequently Asked Questions
What is clinical trial NCT05750173?
NCT05750173 is a Not Applicable OBSERVATIONAL study titled "The EASE-IT CT Registry." It is currently completed and is sponsored by Institut für Pharmakologie und Präventive Medizin. The trial targets enrollment of 150 participants.
What conditions does NCT05750173 study?
This trial investigates treatments for Transcatheter Aortic Valve Implantation (TAVI). The primary condition under study is Transcatheter Aortic Valve Implantation (TAVI).
What treatments are being tested in NCT05750173?
The interventions being studied include: Streamlining of the pre-procedural patient pathway (OTHER). Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.
What does Not Applicable mean for NCT05750173?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05750173?
This trial is currently "Completed." It started on 2023-09-01. The estimated completion date is 2026-03-24.
Who is sponsoring NCT05750173?
NCT05750173 is sponsored by Institut für Pharmakologie und Präventive Medizin. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05750173?
The trial aims to enroll 150 participants. The trial status is completed.
How is NCT05750173 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05750173?
The primary outcome measures are: Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI (30 days); Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI (3 months); Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria (30 days); Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria (30 days). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05750173 being conducted?
This trial is being conducted at 6 sites, including Innsbruck, Tyrol; Sankt Pölten; Vienna; Bad Oeynhausen, North Rhine-Westphalia and 2 more sites (Austria, Germany).
Where can I find official information about NCT05750173?
The official record for NCT05750173 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05750173. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05750173 testing in simple terms?
This study compares two ways to check for heart artery blockages before a valve replacement procedure. It's for older adults (75+) who need a transcatheter aortic valve implantation (TAVI) for severe aortic stenosis.
Why is this trial significant?
This trial aims to see if a less invasive CT scan can safely replace a more invasive procedure for checking heart arteries before a TAVI, potentially making the process quicker and safer for patients.
What are the potential risks of participating in NCT05750173?
The main risk is that a CT scan might miss a significant blockage that an invasive test would find, potentially leading to complications during or after the TAVI procedure. Potential side effects of CT scans are minimal, mainly related to radiation exposure and contrast dye allergies. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05750173?
Ask your doctor if a CT scan alone is sufficient for your pre-TAVI assessment. Participation involves undergoing either a CT scan only or a CT scan followed by a standard invasive test. You will have follow-up appointments at 30 days and 3 months after your procedure. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05750173 signal from an investment perspective?
This trial explores a more efficient pre-procedure pathway for TAVI, a growing market, potentially reducing costs and improving patient throughput. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will either have a CT scan only or a CT scan plus a standard invasive test. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.