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Atrial Fibrillation Ablation Using a Flexible Tip Catheter with Efficient Irrigation Property
-Multicenter, Randomized Controlled Trial with Multiple Output Settings-"

Atrial Fibrillation Ablation Using a Flexible Tip Catheter with Multiple Output Settings

Kuroki Kenji

University of Yamanashi

1110 Shimokato, Chuo, Yamanashi

keng9696@gmail.com

Sudo Koji

University of Yamanashi

Shimokato 1110, Chuo, Yamanashi

+81-55-273-9590

ksudo@yamanashi.ac.jp

Recruiting

July. 15, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients who have been diagnosed with non-valvular atrial fibrillation, who is eligible for catheter ablation, and who can be followed up at the outpatient clinic.
2. Patients who are aged 20 or older and under 80 at the time of obtaining consent (regardless of gender).
3. Patients who provided written consent based on their own free will as research subjects, after receiving sufficient explanation regarding participation in this study.

1. Patients who are contraindicated for antiplatelet therapy or anticoagulant therapy.
2. Patients who have been definitively diagnosed with mitral valve stenosis.
3. Patients who have an implanted artificial valve.
4. Patients who have undergone ventricular or atrial incision surgery within the past 4 weeks.
5. Patients diagnosed with a life expectancy of less than one year due to any illness.
6. Patients with left atrial thrombus.
7. Patients with a left atrial diameter exceeding 50mm.
8. Patients with a history of catheter ablation.
9. Patients with thyroid dysfunction.
10. Patients with cancer.
11. Patients with reduced cardiac function and a left ventricular ejection fraction of less than 50%.
12. Patients with atrial fibrillation persisting for more than 5 years.
13. Patients with atrial fibrillation associated with hypertrophic or dilated cardiomyopathy.
14. Patients with atrial fibrillation and renal dysfunction (eGFR less than 50 mL/min/1.73m2).
15. Pregnant patients.
16. Other patients deemed unsuitable for research participation by the investigators.

Both

Atrial fibrillation

In this study, a three-dimensional mapping system (EnSite X system) will be used, and pulmonary vein isolation procedures will be performed using a flexible tip catheter (TactiFlex, Abbott) in each output group (30W group, 40W group, 50W group) assigned randomly.

The intervention protocols for each group are as follows:
30W group: The output will be set to 30W, and energy delivery will be applied for a maximum of 50 seconds.
40W group: The output will be set to 40W, and energy delivery will be applied for a maximum of 20 seconds.
50W group: The output will be set to 50W, and energy delivery will be applied for a maximum of 10 seconds.

atrial fibrillation

Ablation time for pulmonary vein isolation.

1) Total procedure time for pulmonary vein isolation.
2) Pulmonary vein isolation rate on the first pass.
3) Ablation-related complications for each output setting.
4) Arrhythmia recurrence during the one-year follow-up period.

+81-552736749

May. 22, 2023

Yes

Data is collectid in UHCT ACReSS. The principal investigator or research collaborator enters data into the pre-set Electronic Case Report Form (eCRF) on the Electronic Data Capture (EDC) system and collects and manages the data. The person responsible for creating the eCRF promptly enters the necessary data and ensures that the information for each individual study subject is accurately recorded. Authentication and access rights for the EDC system are managed using ID and password, and data communication is secured through encrypted communication to ensure security.

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