臨床研究等提出・公開システム

Date of registration	July. 01, 2023
Last modified on	Jan. 31, 2024
Trial ID	jRCT1032230199

Scientific Title	Real-world Assessment of QDOT MICRO Catheter-based Pulmonary Vein Isolation with Therapeutic Strategy for Persistent Atrial Fibrillation
Public Title	QUEST AF study

Contact for Scientific Queries	Name	Goya Masahiko
	Affiliation	IUHW Mita Hospital
	Address	1-4-3 Mita, Minato-ku, Tokyo
	Telephone	+81-3-3451-8121
	E-mail	mgoyamd@iuhw.ac.jp
Contact for Public Queries	Name	Suzuki Eri
	Affiliation	Johnson & Johnson K.K. Medical Campany
	Address	5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
	Telephone	+81-80-8400-6517
	E-mail	JJ_clinical@its.jnj.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 31, 2023
Actual date of first enrollment		July. 31, 2023
Target sample size		1000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study: 1.Signed and dated the informed consent form.* 2.Diagnosed with drug refractory symptomatic persistent atrial fibrillation lasting longer than 7 days but less than or equal to 12 months 3.Indicated for AF ablation for symptomatic persistent atrial fibrillation according to the latest version of JCS/JHRS guidelines (at investigators discretion). 4.Scheduled to undergo AF ablation for treatment of their persistent AF using QDOT MICRO catheter 5.Age 18 years or older 6.Able and willing to comply with all pre-, post- and follow-up testing and requirement as per hospital standard of care *When a legal representative of the subject signs the consent, his/her legally acceptable representative must have signed and dated the informed consent form.
	Exclusion Criteria	Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study: 1.Previous surgical or catheter ablation for atrial fibrillation. 2.Presenting any contra-indication for the use of QDOT MICRO catheter, as indicated in the IFU 3.Women of childbearing potential who are, or plan to become, pregnant during the study 4.Not expected to participate in the study for 12-month follow up post-procedure. 5.Currently enrolled or planning to participate in any interventional study 6.Uncontrolled heart failure or New York Heart Association (NYHA) function class IV 7.Life expectancy of less than 12 months
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Persistent AF who are scheduled to undergo an ablation procedure using the QDOT MICRO catheter.
Primary Outcome(s)		Acute Safety -Incidence of Primary Adverse Events (PAEs) related to the device and/or procedure occurring within 7 days post index procedure. Long-term Effectiveness -Freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) episodes based on electrocardiographic data (episodes >=30 seconds) during the effectiveness evaluation period (91-365 days post index procedure).

Primary Sponsor	Johnson & Johnson K.K. Medical Company

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Non-Profit Organization MINS Research Ethics Committee
Address	5-20-9-401, Mita, Minato-ku, Tokyo, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	Jan. 11, 2023

Name of Certified Review Board	Saiseikai Kumamoto Hospital Ethics Committee
Address	5-3-1, Chikami, Minami-ku, Kumamoto-shi, Kumamoto, Tokyo
Telephone	+81-96-351-8000
E-Mail	rks@saiseikaikumamoto.jp
Approval Status	Approval
Date of approval	Jan. 11, 2023

Name of Certified Review Board	Gunma Prefectural Cardiovascular Center Ethics Committee
Address	3-12, kameizumi-machi, maebashi-shi, Gunma, Tokyo
Telephone	+81-27-269-7455
Approval Status	Approval
Date of approval	Jan. 11, 2023

Name of Certified Review Board	Osaka Rosai Hospital Clinical Trialreview Committee
Address	1179-3, Nagasone-cho, Kita-ku, Sakai-shi, Osaka, Tokyo
Telephone	+81-72-252-3561
Approval Status	Approval
Date of approval	Jan. 11, 2023

Name of Certified Review Board	National Hospital Organization Osaka National Hospital Institutional Review Board II
Address	2-1-14, Hoenzaka, Chuo-ku, Osaka-shi, Osaka, Tokyo
Telephone	+81-6-6946-3581
E-Mail	408-chiken@mail.hosp.go.jp
Approval Status	Approval
Date of approval	Jan. 11, 2023

Name of Certified Review Board	Hiroshima City Hiroshima Citizens Hospital Ethics Committee
Address	7-33, Motomachi, Naka-ku, Hiroshima-shi, Hiroshima, Tokyo
Telephone	+81-82-221-2291
Approval Status	Approval
Date of approval	Jan. 11, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 31, 2024	(this page)	Changes
2	Sept. 04, 2023	Detail	Changes
1	July. 01, 2023	Detail

List of change history