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Efficacy and Safety of the wide antral approach during cryoballoon ablation in patients with paroxysmal atrial fibrillation guided by KODEX: a prospective, multicenter, single arm study

Efficacy and Safety of the wide antral approach during cryoballoon ablation in patients with paroxysmal atrial fibrillation guided by KODEX: a prospective, multicenter, single arm study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064383
Enrollment
Unknown
Registered
2022-10-05
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

paroxysmal atrial fibrillation

Interventions

NA: wide antral cryoballoon pulmonary vein isolationn guided by KODEX-EDP system

Sponsors

General Hospital of the Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. >= 18 and <= 75 years of age; 2. Symptomatic PAF with at least one episode documented (30 seconds episode length, documented by ECG within last 12 months); 3. Documented treatment failure for the effectiveness of at least one anti-arrhythmic drug (AAD Type I or III, including ß-blocker and AAD intolerance); 4. Patients who are mentally and linguistically able to understand the aim of the trial and show sufficient compliance in following the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation secondary to electrolyte disturbances, hyperthyroidism, or other reversible non-cardiac causes; 2. Any previous left atrial (LA) ablation or surgery (including left atrial appendage (LAA) occlusion); 3. LAA thrombus or LA thrombus; 4. Pulmonary vein (PV) stenosis or PV stent; 5. Repair of atrial septal defect or LA myxoma; 6. Anteroposterior LA diameter >= 50mm; 7. LVEF < 40%; 8. New York Heart Association (NYHA) Class III or IV congestive heart failure; 9. TIA or stroke within 3 months prior to enrolment; 10. Cardiovascular events within 3 months prior to enrolment; 11. Active systemic infection; 12. Severe liver or renal dysfunction; 13. Significant bleeding tendency or hematological disorders; 14. Patients with an advanced malignant tumor; 15. Rheumatic heart disease; 16. One-stop procedure is planned at the same time; 17. Pregnant women, breastfeeding women, or women of childbearing potential not on adequate birth control; 18. Participation in another clinical trial (of a drug, device, or biologic), either within the past two months or ongoing; 19. Diseases or abnormal cases that are not suitable for the clinical trial.

Design outcomes

Primary

MeasureTime frame
freedom from atrial arrhythmias recurrence rate;—

Countries

China

Contacts

Public ContactZulu Wang

General Hospital of the Northern Theater Command

wangzulu62@126.com+86 24 28897261

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026