HotBalloon Pulmonary Vein isolation Registry Study - HARVEST Study -

HotBalloon Pulmonary Vein isolation Registry Study - HARVEST Study - - HotBalloon Registry Study - HARVEST Study -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029567

Enrollment

600

Registered

2017-10-16

Start date

2017-11-22

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is over 20 years old of age 2. Planned catheter-ablation of atrial fibrillation using SATAKE?HotBalloon Catheter

Exclusion criteria

Exclusion criteria: 1. Subjects within life expectancy one year 2. Subjects who are judged inappropriate for the study by the physician

Design outcomes

Primary

Measure	Time frame
Twelve-month freedom from atrial fibrillation (AF) recurrence	—

Countries

Japan

Contacts

Public ContactYuki Nishiura

Mebix, Inc. Development Div.

harvest@mebix.co.jp03-4362-4504

Outcome results