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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 - 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 (IDEAL-PVI study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044871
Enrollment
200
Registered
2021-08-01
Start date
2021-09-01
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

Atrial fibrillation

Interventions

&lt
High Ablation Index Group&gt
The left pulmonary vein is ablated with an Ablation Index of 550-600 from the anterior wall of the left superior pulmonary vein, 600-650 from the anterior wall of the left carina, 400 from the anterio
Low Ablation Index group&gt
The left pulmonary vein is ablated with an Ablation Index of 550 for the anterior wall of the carina, and 400 from the anterior wall of the left inferior pulmonary vein to the posterior wall. (When th

Sponsors

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients who will undergo the first ablation for atrial fibrillation. (2) Females and males who are aged 20 years or older and 85 years or younger at the time of consent acquisition/enrollment date. (3) The patient's written consent for participation in the study has been obtained.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to anticoagulation. (2) Patients with thrombus in the left atrium. (2) Patients with intra-left atrial thrombus. (3) Other patients who are judged by the investigator or sub-investigator to be unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Acute effects of extended encircling pulmonary vein isolation by high Ablation Index (presence of first-pass pulmonary vein isolation, presence of reconduction after waiting, presence of dormant conduction by ATP administration)

Secondary

MeasureTime frame
Assessment of safety of high Ablation Index (complications, procedure time, fluoroscopy time)

Countries

Japan

Contacts

Public ContactShushi Nishiwaki

Graduate School of Medicine, Kyoto University Department of Cardiovascular Medicine

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

Outcome results

None listed

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