NCT06699368Not yet recruiting
Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters
Source: ClinicalTrials.gov · Last updated 21 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 28 Nov 2024
- Primary completion date
- 5 May 2025
- Lead sponsor
- The Third People's Hospital of Chengdu
- Diseases
- Atrial fibrillation
- NCT number
- NCT06699368
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 28 Nov 2024 to the primary completion date, 5 May 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
- Patients who are concurrently participating in other drug or device clinical trials;
Other illness
- Atrial fibrillation secondary to thyroid disease or other reversible factors;
- Unstable angina;
- Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
- Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
- Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Conditions affecting vascular access;
- Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.
Lab values
- Left ventricular ejection fraction \<40%, or New York Heart Association (NYHA) functional class III or IV;
Other
- Imaging studies indicating intracardiac thrombus;
- Moderate to severe mitral stenosis or regurgitation;
- Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
Who the study is looking for
- Patients aged between 18 and 80 years old.
- Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.
- Non-valvular atrial fibrillation.
- Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.