UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intervention study on determination of optimal AV / VV Delay in patients implanted with CRT using electrocardiogram
Title of the study (Brief title)	New Ishikawa's CRT Method study (NICM study)
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To enable easy setting of AV / VV Delay which takes approximate value of optimal AV Delay determined using echocardiography while suppressing right ventricular pacing in CRT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BNP EF(Modified Simpson) LVDs LVDd LAD Time taken to set AV/VV delay
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Measure PQ interval at A Sense When the 150 msPQ interval is less than 150 ms, the PQ interval is -40 ms, the LV preceding 30 ms When the PQ interval is 150 ms to 200 ms, the PQ interval is -50 ms, the LV preceding 30 ms When the PQ interval is 200 ms or more, set PQ interval 120 ms, LV-RV simultaneous pacing. This study is a crossover study for 3 months, after 3 months we change the setting from 1 group to 2 groups and finish in 6 months.
Interventions/Control_2	Set AV delay by cardiac ultrasound examination and set VV delay to 0 ms.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients participating in this study must meet all the criteria shown below. 1.Patients meeting the criteria for CRT / CRTD implantation according to guidelines of the Japanes Circulation Society. 2. Patients who have implanted or implanted CRT system. 3.Patients who are able to visit regular follow-up according to protocol. 4 Patient who received explanation about this study and agreed.
Key exclusion criteria	Patients eligible for at least one of the following exclusion criteria can not participate in this study. 1. Patients whose predicted life expectancy is less than 1 year 2. Patients who may undergo heart transplant surgery within one year 3. Patients with persistent atrial fibrillation
Target sample size	50

Research contact person
Name of lead principal investigator	Toshiyuki Ishikawa
Organization	yokohama city university hospital
Division name	Department of Cardiology
Address	3-9 Fukuura, kanazawa-ku, YOkohmama 236-0004 Japan
TEL	045-787-2800
Email	tishika@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Tabito Kino
Organization	yokohama city university hospital
Division name	Department of Cardiology
Address	3-9 Fukuura, kanazawa-ku, YOkohmama 236-0004 Japan
TEL	045-787-2800
Homepage URL
Email	kino-tabito@umin.ac.jp

Sponsor
Institute	Department of Cardiology, Yokohama City University Hospital
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035988