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Prospective multicenter randomized study comparing two different ablation systems for treatment of persistent atrial fibrillation (PULSAR AF study)

Prospective multicenter randomized study comparing two different ablation systems for treatment of persistent atrial fibrillation (PULSAR AF study) - PULSAR AF study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055949
Enrollment
110
Registered
2025-01-01
Start date
2025-01-01
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

Persistent atrial fibrillation

Interventions

Ablation using the PulseSelect (Medtronic) Ablation using the Polarx FIT (Boston Scientific)

Sponsors

Institute of Science Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with initial ablation for persistent atrial fibrillation

Exclusion criteria

Exclusion criteria: Patients who underwent prior cardiac surgery Patients with cardiovascular implantable electronic device Patients with left atrial appendage device Patients who are not considered to be suitable candidates by the attending physician

Design outcomes

Primary

MeasureTime frame
Freedom from any documented atrial tachyarrhythmias during 12 months follow-up after a single ablation procedure beyond 3 months of blanking period

Secondary

MeasureTime frame
Incidence of complication Incidence of phrenic nerve injury Procedural duration, fluoroscopy time, dose of contrast Freedom from repeat ablation procedure Freedom from direct current cardioversions for recurrent arrhythmias Pulmonary vein isolation durability and the location of conduction resumption during second procedure

Countries

Japan

Contacts

Public ContactSHINSUKE MIYAZAKI

Institute of Science Tokyo Department of cardiovascular medicine

mshicvm@tmd.ac.jp03-5803-5231

Outcome results

None listed

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