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A multi center, prospective study on the clinical safety and effectiveness evaluation of a new magnetic navigation radiofrequency ablation catheter used in tachycardia arrhythmias

A multi center, prospective study on the clinical safety and effectiveness evaluation of a new magnetic navigation radiofrequency ablation catheter used in tachycardia arrhythmias

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091627
Enrollment
Unknown
Registered
2024-10-31
Start date
2024-11-04
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tachycardia arrhythmia includes paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia

Interventions

Radiofrequency ablation with new saline infusion catheter using remote magnetic navigation system:a new saline infusion catheter would be used during radiofrequency ablation

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily signed a written informed consent, committed to following the research procedures, cooperated with the entire research process; 2. 18 years old = Patient age = 80 years old, gender is not limited; 3. Paroxysmal atrial fibrillation or symptomatic supraventricular tachycardia: i. For paroxysmal atrial fibrillation, atrial fibrillation was recorded by ECG or dynamic electrocardiogram (including single lead ECG recorder) within 1 year before enrollment; ii. For supraventricular tachycardia, PSVT (AVNRT or AVRT) was recorded by ECG, Holter or electrophysiological examination. 4. Intolerance or refractory to at least one antiarrhythmic drug, or patients who are willing to undergo ablation surgery without medication treatment. 5. NYHAI-II; 6. LVEF> 50%; 7. Antiarrhythmic drugs should be discontinued for 5 half lives before surgery;

Exclusion criteria

Exclusion criteria: 1.Left atrial thrombus (PSVT not applicable); 2.LAD=55mm (PSVT not applicable); 3.LVEF=40%; 4.Previous history with atrial septal repair or atrial myxoma (PSVT not applicable); 5.Carrying implants (such as pacemakers, ICD, etc.) or other specific devices that may affect the effectiveness of research interventions; 6.NYHA III-IV; 7.Patients with confirmed cerebrovascular disease (including cerebral hemorrhage, stroke, and transient ischemic attack) within the past 6 months; 8.Patients experienced cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention therapy or coronary bypass surgery, artificial valve replacement or repair surgery, atrial or ventricular incision surgery); 9.Patients with acute or severe systemic infections within one month prior to screening; 10.Patients combined with severe liver and kidney diseases, malignant tumors, or end-stage disease which may interfere with the treatment, evaluation, and compliance of this study; 11.During pregnancy or lactation; 12.Individuals with obvious bleeding tendency, hypercoagulability, or severe hematological disorders; 13.Serious mental health issues or other physical health conditions; 14.Any other conditions that may not suitable in the researchers' opinion should be excluded;

Design outcomes

Primary

MeasureTime frame
The non-recurrence rate of cardiac arrhythmia after 3 months;

Secondary

MeasureTime frame
Compatibility evaluation of new catheters and supporting devices;Immediate success rate after catheter ablation;Safety evaluation;

Countries

China

Contacts

Public ContactQI Jin

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

jinqi127@163.com+86 21 64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026