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optimal ablation InDEx for Atrial fibriLlation during extensive encircling Pulmonary Vein Isolation study

A Multicenter, Randomized, Parallel-Group Study of the Efficacy and Safety of a Low Ablation Index Group versus a High Ablation Index Group during Extensive Encircling Pulmonary Vein Isolation for Atrial Fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052210122
Enrollment
200
Registered
2021-11-17
Start date
2021-11-17
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

Interventions

Low Ablation Index group The left pulmonary vein is energized with a target Ablation Index of 550 from the canopy to the anterior wall of the carina, and 400 from the anterior wall of the left inferio
Catheter ablation

Sponsors

Shizuta Satoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the following criteria should be met. (1) Patients undergoing initial ablation for atrial fibrillation (regardless of duration). (2) Female/male patients who are aged 20 years or older and 85 years or younger at the time of consent/enrollment.

Exclusion criteria

Exclusion criteria: Patients should be excluded if any of the following conditions apply (1) Patients with contraindications to anticoagulation. (2) Patients with thrombus in the left atrium. (3) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Acute effects of expanded pulmonary vein isolation by High Ablation Index (successful isolation in one round of pulmonary vein energization, presence of reconduction after waiting, presence of dormant conduction by ATP administration)), safety evaluation (complications, procedure time, fluoroscopy time)

Secondary

MeasureTime frame
Chronic phase effects of expanded pulmonary vein isolation by High Ablation Index (excluding the blanking period within 3 months after ablation, the rate of recurrent atrial arrhythmias lasting longer than 30 seconds at 12 months, status under antiarrhythmic medication, and changes in quality of life).

Contacts

Public ContactShushi Nishiwaki

Kyoto University Hospital

s_nishiwaki@kuhp.kyoto-u.ac.jp+81-75-751-4255

Outcome results

None listed

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