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Clinical Trials in China / NCT06850064
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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

NCT06850064 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chest Hospital
Phase
Not applicable
Started
2025-02-24
Last updated
2025-02-27

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Pulse Field Ablation (PFA)Radiofrequency ablation

Pulse Field Ablation (PFA): The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.

Radiofrequency ablation: In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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: 1. Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes. 2. 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 Criteria: 1. Pregnant or breastfeeding women. 2. Presence of left atrial thrombus on preoperative imaging. 3. Life expectancy less than 1 year. 4. Coagulation disorders or contraindications to anticoagulant therapy.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai China

More Shanghai Chest Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06850064 on ClinicalTrials.gov ↗ ← All trials in China