NCT06694610Not yet recruiting
A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping
Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Nov 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 5 Apr 2025
- Lead sponsor
- The Third People's Hospital of Chengdu
- Diseases
- Atrial fibrillation
- NCT number
- NCT06694610
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Nov 2024 to the primary completion date, 5 Apr 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 18 to 85 years;
- Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.
- Non-valvular atrial fibrillation;
- Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study 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.