Electrophysiology Testing to Stratify Patients With Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.
Sven Knecht, Beat Schaer, Tobias Reichlin...
https://pubmed.ncbi.nlm.nih.gov/32089049Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06189976
Rapid Atrial Pacing After TAVI as a Predictor of Permanent Pacemaker Implantation
Led by National and Kapodistrian University of Athens · Updated on 2024-12-12
400
Participants Needed
2
Research Sites
35 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
Researchers are studying patients undergoing Transcatheter Aortic Valve Implantation (TAVI) to address the challenge of needing permanent pacemaker implantation (PPI) after TAVI. This trial investigates the use of rapid atrial pacing (RAP), a simple test using a temporary pacemaker lead, as a way to predict which patients might require PPI. The study aims to clarify the value of RAP in improving decision-making post-TAVI given the current variability in PPI rates and the impact of PPI on long-term health outcomes. The study involves placing a temporary pacemaker lead in the right atrium before and after the TAVI procedure in patients who are stable and not dependent on a pacemaker. RAP is performed by increasing the pacing rate until a certain type of atrioventricular block is observed or a maximum rate of 150 beats per minute is reached. The test is done twice, before and after the valve implantation, to record the heart's response to pacing. Participants will be closely monitored during the procedure and follow-up visits. Data collected include electrocardiograms and RAP test results, with ongoing recording of any adverse events. The main outcome measured is the rate of permanent pacemaker implantation within 30 days after TAVI, along with mortality and PPI rates tracked at 6 and 12 months. Investigators will maintain detailed records throughout the trial to ensure safety and accurate data reporting.
CONDITIONS
Brief Title
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Patient understands the trial purpose, risks, and benefits and agrees to follow-up
- Patient has signed informed consent
- Patients undergoing TAVI for severe aortic stenosis
- Patient is in normal sinus rhythm
- Patients planned for TAVI with temporary pacemaker electrode placement
You will not qualify if you...
- Active infection, including endocarditis
- Existing 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 on pre-TAVI ECG
- Participation in another interfering study
- Unable to comply with follow-up requirements
- Pregnant or breastfeeding females or intending pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure day
Participants undergo Transcatheter Aortic Valve Implantation (TAVI) with temporary pacemaker electrode placement. Rapid atrial pacing (RAP) tests are performed before and after the TAVI procedure to assess atrioventricular conduction.
1 visit (in-person) on the day of TAVI
Long-term Monitoring
Duration - 12 months
Participants are monitored for permanent pacemaker implantation and mortality outcomes for up to 12 months following the TAVI procedure.
Follow-up visits as per local practice up to 12 months
Trial Site Locations
Total: 2 locations
1
CHU Saint-Pierre
Brussels, Belgium, 1000
Actively Recruiting
2
Hippocration Hospital
Athens, Attica, Greece, 11527
Actively Recruiting
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Research Team
L
Leonidas Koliastasis, MD, PhD
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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Published Research Related To This Trial
The Utility of Rapid Atrial Pacing Immediately Post-TAVR to Predict the Need for Pacemaker Implantation.
Amar Krishnaswamy, Yasser Sammour, Antonio Mangieri...
https://pubmed.ncbi.nlm.nih.gov/32305392Utility of rapid atrial pacing before and after TAVR with balloon-expandable valve in predicting permanent pacemaker implantation.
Bryan E-Xin Tan, Anas Hashem, Leela K T Boppana...
https://pubmed.ncbi.nlm.nih.gov/37698294Rapid Atrial Pacing After TAVI for Pacemaker Prediction.
Leonidas Koliastasis, Ioannis Doundoulakis, Dimitrios Tsiachris...
https://pubmed.ncbi.nlm.nih.gov/40927105