Prospective multicenter randomized study comparing two different pulsed field ablation systems for treatment of paroxysmal atrial fibrillation (DUAL-PULSE Study)

Prospective multicenter randomized study comparing two different pulsed field ablation systems for treatment of paroxysmal atrial fibrillation (DUAL-PULSE Study) - DUAL-PULSE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056534

Enrollment

180

Registered

2025-02-01

Start date

2025-02-01

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

Paroxysmal atrial fibrillation

Interventions

Ablation using the PulseSelect (Medtronic) Ablation using the Farapulse (Boston Scientific)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with initial ablation for paroxysmal 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

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

Secondary

Measure	Time frame
Incidence of complication Procedural duration, fluoroscopy time Freedom from the repeat ablation procedure Freedom from direct current cardioversions for recurrent arrhythmias Pulmonary vein isolation durability and the location of conduction resumption during the 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