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A Multicenter Prospective Randomized Interventional Study Examining the Impact of Wide Interlesion Distance in High Power Short Duration Atrial Fibrillation Ablation Using the TactiFlex

A Multicenter Prospective Randomized Interventional Study Examining the Impact of Wide Interlesion Distance in High Power Short Duration Atrial Fibrillation Ablation Using the TactiFlex - WILD PVI trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042230052
Enrollment
204
Registered
2023-06-25
Start date
2023-10-17
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

Atrial fibrillation Atrial fibrillation, ablation, interlesion distance

Interventions

Allocation of catheter ablation treatment method for atrial fibrillation (5mm tag group and 7mm tag group).
catheter ablation

Sponsors

Naruse Yoshihisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. patients between 20 and 80 years of age 2. patients diagnosed with paroxysmal atrial fibrillation and scheduled for first catheter ablation procedure (using TactiFlex) 3. Patients who have given their consent to participate in this study by signing a consent form in person.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be included in this study 1. Patients with a history of catheter ablation for atrial fibrillation 2. Patients with serious renal disease (on hemodialysis) 3. women who are lactating, pregnant, or of childbearing potential 4. patients with symptomatic heart failure (NYHA III degree or higher).

Design outcomes

Primary

MeasureTime frame
Initial Success Rate of Pulmonary Vein Isolation Line Initial success of pulmonary vein isolation line is defined as when either of the following two conditions is met 1: Successful first pass isolation and no premature re-conduction of the pulmonary vein at least 30 minutes after pulmonary vein isolation. 2: When the failure of first pass isolation and early re-conduction is due solely to early excitation in the pulmonary vein by epicardial conduction and the pulmonary vein isolation line is evaluated to be complete. The left and right pulmonary veins will be evaluated separately for each subject in the study.

Secondary

MeasureTime frame
Success rate of first pass isolation Early nonreconduction rate Number of cauterizations Cauterization time Procedure time Fluoroscopy time Ablation-related complications

Contacts

Public ContactYoshihisa Naruse

Hamamatsu University School of Medicine

ynaruse@hama-med.ac.jp+81-53-435-2356

Outcome results

None listed

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