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The Single-center Prospective Randomized Controlled Trial Evaluating Efficacy and Safety of Catheter Ablation without Periprocedual Contrast Media for Paroxysmal Atrial Fibrillation: Sophisticated Atrial Fibrillation ablation procedurE contrasT media unnecessitY (SAFETY) trial

The Single-center Prospective Randomized Controlled Trial Evaluating Efficacy and Safety of Catheter Ablation without Periprocedual Contrast Media for Paroxysmal Atrial Fibrillation: Sophisticated Atrial Fibrillation ablation procedurE contrasT media unnecessitY (SAFETY) trial - SAFETY trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023100
Enrollment
100
Registered
2016-09-10
Start date
2016-09-10
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Paroxysmal atrial fibrillation

Interventions

Patients are randomized in a 1:1 ratio to catheter ablation for paroxysmal atrial fibrillation with or without periprocedual contrast media. In contrast group,contrast media was used for 3D mapping l

Sponsors

Kyoto University Graduate School of Medicine,
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing first catheter ablation for paroxysmal atrial fibrillation, who are 20-80 years old, able to be followed for one year in an out-patient clinic and willing to sign the consent form for participation, are eligible for the study.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy for contrast media 2) Patients with renal insufficiency (eGFR <=45ml/min/1.73m2 3) Left ventricular ejection fraction < 40% 4) Left atrial diameter > 50mm 5) Patients with a history of open heart surgery 6) Patients with moderate or severe valve heart disease 7) Patients who need additional ablation such as tricuspid valve isthmus ablation during procedure 8) Patients unwilling to sign the consent form for participation

Design outcomes

Primary

MeasureTime frame
Event-free rate from atrial tachyarrhythmia after procedure

Secondary

MeasureTime frame
Any procedural complications Total time required for mapping of left atrium during procedure Total procedure time Total fluoroscopy time Total radiation dose Total number of energy applications Incidence of dormant conduction Renal function after procedur

Countries

Japan

Contacts

Public ContactTetsuma Kawaji

Kyoto University Graduate School of Medicine, Department of Cardiology

kawaji@kuhp.kyoto-u.ac.jp075-751-4255

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026