臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 19, 2020
Last modified on	Mar. 29, 2023
Trial ID	jRCTs042200051

Scientific Title	Catheter Ablation versus Medical treatment in Patients with Mitral Regurgitation who implanted percutaneous mitral valve repair and Atrial Fibrillation (CAMP-MRAF TRIAL)
Public Title	Catheter Ablation for Atrial Fibrillation After Percutaneous Mitral Valve Repair

Completion date	Mar. 15, 2023
Result actual enrolment	1
Baseline Characteristics	Heart failure patients with atrial fibrillation accompanied by percutaneous mitral valve repair
Participant flow	An enrolled patient was performed catheter ablation.
Adverse events	not applicable
Outcome measures	not applicable
Brief summary	not applicable
Date of posting of results summaries	Mar. 15, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs042200051

Contact for Scientific Queries	Name	Kinugawa Koichiro
	Affiliation	Second department of internal medicine, University of Toyama
	Address	2630 Sugitani, Toyama
	Telephone	+81-76-434-7297
	E-mail	kinugawa@med.u-toyama.ac.jp
Contact for Public Queries	Name	Kataoka Naoya
	Affiliation	Second department of internal medicine, University of Toyama
	Address	2630 Sugitani, Toyama
	Telephone	+81-76-434-7297
	E-mail	nkataoka@med.u-toyama.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 19, 2020
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients undergoing percutaneous mitral valve repair (PMVR) for mitral regurgitation 2) Patients with paroxysmal or persistent atrial fibrillation. Diagnosis of atrial fibrillation is performed with a 12-lead electrocardiogram, a Holter electrocardiogram, an implantable device (ICD / CRT-D / loop recorder), or a portable electrocardiograph. Case registration is limited to cases where atrial fibrillation has been recorded within one year retroactively from study registration. 3) Age at the time of PMVR treatment is 20 years old or older and less than 90 years old
	Exclusion Criteria	1) Patients undergoing percutaneous mitral valve repair (PMVR) for mitral regurgitation 2) Patients with paroxysmal atrial fibrillation (2 or more events lasting 30 seconds or more). Even if atrial fibrillation persists for 7 days or more, it is registered as paroxysmal atrial fibrillation when it becomes sinus rhythm by drug or cardioversion and then becomes paroxysmal atrial fibrillation. Diagnosis of atrial fibrillation is performed with a 12-lead electrocardiogram, a Holter electrocardiogram, an implantable device (ICD / CRT-D / loop recorder), or a portable electrocardiograph. Case registration is limited to cases where atrial fibrillation has been recorded within one year retroactively from study registration. 3) Age at the time of PMVR treatment is 20 years old or older and less than 90 years old
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrial Fibrillation
Intervention(s)		arm Catheter Ablation: cryoballoon ablation for atrial fibrillation. arm Drug: Drugs for atrial fbirillation will be continued.
Health Condition(s) Keyword		Heart Failure, Mitral Regurgitation, Percutaneous Mitral Valve Repair, Atrial Fibrillation
Intervention(s) Keyword
Health Condition(s) Code		053
Intervention(s) Code
Primary Outcome(s)		BNP, NT-proBNP
Secondary Outcome(s)		All-cause death, Heart failure hospitalization, stroke, major bleeding

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Medtronic Japan Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Clinical Research Review Board, University of Toyama
Address	2630, Sugitani, Toyama, Toyama
Telephone	+81-76-415-8857
E-Mail	rinken@adm.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Sept. 11, 2020

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Mar. 29, 2023	(this page)	Changes
3	Feb. 28, 2023	Detail	Changes
2	Feb. 08, 2023	Detail	Changes
1	Oct. 19, 2020	Detail

List of change history