Cavo-Tricuspid Isthmus Block Durability After Pulsed Electric Field Ablation
Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Nov 14, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment for a type of heart flutter called Cavotricuspid Isthmus (CTI) dependent right atrial flutter. The researchers want to find out how effective a special method called Pulsed Electric Field (PEF) ablation is at stopping this flutter and how long the effects last. They will also investigate the best time to check if the heart has returned to normal after the treatment and whether a specific test can help identify any lingering issues. Additionally, the study will compare two different types of catheters used in this procedure to see if one works better than the other and if there are any side effects.
To participate in this trial, individuals should be at least 18 years old and have specific types of heart conditions that require treatment. However, some people may not be eligible, such as those with certain heart conditions, significant health issues, or previous heart surgeries. Participants can expect close monitoring during and after the procedure, and they will provide consent before joining the study. This trial is currently recruiting and aims to improve treatment options for people with this heart flutter condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients with paroxysmal AF undergoing PVI by PEF energy with documented typical atrial flutter or patients with persistent AF in whom catheter ablation of CTI is planned as a part of a complex procedure
- • Age ≥ 18 years at the time of study enrollment
- • Signed informed consent
- Exclusion Criteria:
- • - LA diameter \> 65 mm (measured in the parasternal long-axis view)
- • History of CTI ablation in the past
- • History of cardiac valve surgery
- • Significant valvular defect
- • Age below 18 years
- • Pregnancy, breastfeeding
- • Any disease with a life expectancy \<1 year
- • Uncorrected congenital heart disease or valvular obstruction
- • Active myocarditis
- • Untreated hypothyroidism or hyperthyroidism
- • Recipient of any major organ transplant (e.g., lung, liver, heart)
- • HIV positivity with a survival expectancy of less than five years due to HIV
- • Chronic dialysis treatment
- • Unwillingness to participate.
About Institute For Clinical And Experimental Medicine
The Institute for Clinical and Experimental Medicine (IKEM) is a leading research institution dedicated to advancing healthcare through innovative clinical and experimental studies. With a strong emphasis on translational research, IKEM aims to bridge the gap between laboratory discoveries and clinical applications, fostering collaboration among scientists, healthcare professionals, and industry partners. Its state-of-the-art facilities and multidisciplinary approach enable robust investigations into a wide range of medical conditions, ultimately striving to improve patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prague, , Czech Republic
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported