Use of adenosine to shorten the post ablation waiting period for cavotricuspid isthmus-dependent atrial flutter.
Gustavo Morales, Yousef H Darrat, Nicolas Lellouche...
https://pubmed.ncbi.nlm.nih.gov/28429528Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06691074
Systematic Assessment of the Acute Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-11-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the immediate effectiveness and durability of the cavo-tricuspid isthmus (CTI) block using pulsed electric field (PEF) energy in patients with atrial fibrillation (AF) and typical atrial flutter. The study will also determine the best waiting time to detect recovery of conduction after PEF CTI ablation and assess the usefulness of routine adenosine testing for dormant conduction. Additionally, it compares two catheter configurations, basket and flower, to study differences in acute success and side effects like hemolysis and coronary vasospasm. Participants undergo catheter ablation of the CTI using either the flower or basket configuration of the Farapulse catheter in a randomized 1:1 assignment. Ablations are performed during atrial pacing under anesthesia with intracardiac echocardiography guidance. Patients receive sublingual nitrates before ablation, and sequential PEF applications are delivered until CTI block is achieved. Adenosine testing for dormant conduction and monitoring of conduction recovery times are performed during the procedure. Blood samples to measure plasma biomarkers are collected before and after CTI isolation. Throughout the study, patients are monitored using catheters in the heart, electrocardiograms, and intracardiac imaging. Researchers measure the acute durability of the CTI block, time to conduction recovery, presence of dormant conduction via adenosine testing, plasma hemoglobin levels, and coronary vasospasm occurrence. The study includes 150 patients aged 18 and older, with follow-up during the ablation procedure to assess these outcomes under continuous observation. The total participation time corresponds to the duration of the ablation procedure and associated assessments.
CONDITIONS
Brief Title
Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation by pulsed electric field energy with documented typical atrial flutter or patients with persistent atrial fibrillation planned for catheter ablation of the CTI as part of a complex procedure
- Age 18 years or older at the time of study enrollment
- Signed informed consent
You will not qualify if you...
- Left atrial diameter greater than 65 mm
- History of previous CTI ablation
- History of cardiac valve surgery
- Significant valvular defect
- Age below 18 years
- Pregnancy or breastfeeding
- Any disease with life expectancy less than 1 year
- Uncorrected congenital heart disease or valvular obstruction
- Active myocarditis
- Untreated hypothyroidism or hyperthyroidism
- Recipient of any major organ transplant
- HIV positivity with survival expectancy less than 5 years due to HIV
- Chronic dialysis treatment
- Unwillingness to participate
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 - Single procedure day
Participants undergo catheter ablation of the cavotricuspid isthmus (CTI) using either the flower or basket configuration of the Farapulse catheter under general anesthesia or deep sedation. The procedure includes placement of diagnostic catheters, pulsed electric field (PEF) energy applications to achieve CTI block, and assessment of block durability and conduction recovery during the same procedure.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Institute for Clinical and Experimental Medicine
Prague, Prague, Czechia, 14200
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Conduction Recovery After Cavotricuspid Isthmus Ablation When Performed With or Without Concomitant Atrial Fibrillation Ablation.
Zachary T Yoneda, M Benjamin Shoemaker, Travis Richardson...
https://pubmed.ncbi.nlm.nih.gov/32819535Acute resumption of conduction in the cavotricuspid isthmus after catheter ablation in patients with common atrial flutter. Real-time evaluation and long-term follow-up.
J Chen, C de Chillou, O J Ohm...
https://pubmed.ncbi.nlm.nih.gov/12134971