Comparing two heart ablation methods for a hard-to-treat heart rhythm problem
Compares pulsed field ablation with radiofrequency ablation in adults with atrial flutter.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting atrial flutter (a fast, regular heart rhythm) that has not responded to earlier treatment. It compares two ways of treating the heart: pulsed field ablation and radiofrequency ablation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Persistent atrial flutter with symptoms that depends on the mitral valve area and has not responded to treatment (refractory)
- Earlier treatment
- Heart rhythm medicine (Class I or III) did not control the flutter. At least one earlier radiofrequency catheter ablation at the mitral valve area failed. The person cannot tolerate at least one heart rhythm medicine.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Blood clot in the left atrium seen on imaging before the procedure
- Life expectancy of less than 1 year
- Bleeding or clotting disorders, or a reason not to take blood thinners
Read by machine on 9 November 2026.
Where in China
- Shanghai Chest HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Chest Hospital
- Trial code
- NCT06850064
- Record updated
- 27 February 2025
- Original description
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled studyRead full original descriptionShow less
Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
Inclusion: 1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:; Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes; Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure); 3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.
Exclusion: Coagulation disorders or contraindications to anticoagulant therapy; Pregnant or breastfeeding women; Presence of left atrial thrombus on preoperative imaging; Life expectancy less than 1 year.