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New treatment option for Aortic Valve Disease
Official title Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
ClinicalTrials.gov ID: NCT06189976
What this study is testing
- What it's testing
- Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback. The electrophysiology testing to stratify the risk or necessity of PPI post-TAVI is endorsed by the up-to-date guidelines and consensus documents and it is a valuable cut-off based method.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥18 years old.
- Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
- Patient has given written consent to participate in the trial.
- Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).
- Patient in sinus rhythm.
You likely can't join if
- Ongoing infection, including active endocarditis.
- Implanted permanent pacemaker and/or implantable cardioverter/defibrillator.
- Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.
- Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.
- Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.
- Enrolment in another study that competes or interferes with this study.
See the full eligibility criteria
- Adults ≥18 years old.
- Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
- Patient has given written consent to participate in the trial.
- Patients undergoing TAVI as a treatment of severe aortic stenosis (AS).
- Patient in sinus rhythm.
- Patients planned for TAVI with utilization of temporary pacemaker electrode placement.
- Ongoing infection, including active endocarditis.
- Implanted permanent pacemaker and/or implantable cardioverter/defibrillator.
- Patients developing persistent second or third degree atrioventricular block (AV) after TAVI.
- Underlying rhythm other than sinus based on the surface ECG leads monitoring after TAVI.
- Patients with second or third degree AV block identifyied on the screening pre-TAVI ECG.
- Enrolment in another study that competes or interferes with this study.
- Subject will not be able to comply with the follow-up requirements according to investigators' opinion.
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Athens, Attica, Greece
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Athens, Attica, Greece. 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.