Actively Recruiting
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Led by National and Kapodistrian University of Athens · Updated on 2024-12-12
400
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
C
Centre Hospitalier Universitaire Saint Pierre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Part of the answer is maybe hidden in the easy and applicable testing of the atrioventricular conduction system through rapid atrial pacing (RAP) with a common temporary pacemaker lead. This trial is designed to investigate the role and value of RAP after TAVI as a predictor of the necessity of new PPI.
CONDITIONS
Official Title
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Patient understands the trial purpose, risks, and benefits and is willing to participate in all follow-up parts
- Patient has given written consent to join the trial
- Patients undergoing TAVI for severe aortic stenosis
- Patient is in sinus rhythm
- Patients planned for TAVI with temporary pacemaker electrode placement
You will not qualify if you...
- Ongoing infection, including active endocarditis
- Implanted permanent pacemaker or implantable cardioverter/defibrillator
- Persistent second or third degree atrioventricular block after TAVI
- Heart rhythm other than sinus after TAVI
- Second or third degree atrioventricular block identified on pre-TAVI ECG
- Participation in another conflicting clinical study
- Unable to comply with follow-up requirements as judged by investigators
- Pregnant or breastfeeding females or females planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CHU Saint-Pierre
Brussels, Belgium, 1000
Actively Recruiting
2
Hippocration Hospital
Athens, Attica, Greece, 11527
Actively Recruiting
Research Team
L
Leonidas Koliastasis, MD, PhD
CONTACT
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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