UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy
Title of the study (Brief title)	SMART CRT
Region	Japan North America Europe

Condition
Condition	Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary endpoint is comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. CRT response is defined by a decrease in Left Ventricular End Systolic Volume (LVESV) >= 15% at 6 months compared to pre-implant baseline.
Basic objectives2	Others
Basic objectives -Others	To show the benefit of SmartDelay in patients with a prolonged RV-LV interval
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Left Ventricular End Systolic Volume (LVESV) >= 15% at 6 months compared to pre-implant baseline.
Key secondary outcomes	Clinical Composite Endpoint All-cause mortality Heart failure events NYHA Class Quality of Life (patient Global Assessment instrument) Six-minute walk distance Kansas City Cardiomyopathy Questionnaire Left-ventricular ejection fraction (LVEF)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms in CRT.
Interventions/Control_2	1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms in CRT.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device. In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: - Moderate to severe heart failure (NYHA Class III-IV) with EF <= 35% and QRS duration >=120 ms - Left bundle branch block (LBBB) with QRS duration >=150 ms, EF <=30%, and mild (NYHA Class II) ischemic or nonischemic heart failure Subject is age 20 or above Subject is willing and capable of providing informed consent Subject is willing and capable of complying with visits and procedures as defined by this protocol
Key exclusion criteria	Subjects with documented permanent complete AV block Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD) Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc) Subject with a known or suspected sensitivity to dexamethasone acetate (DXA) Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific Women of childbearing potential who are or plan to become pregnant during the course of the trial Subjects currently requiring dialysis
Target sample size	726

Research contact person
Name of lead principal investigator	Dr. Michael Gold
Organization	Medical University of South Carolina
Division name	Division of Cardiology
Address	114 Doughty Street MSC 592 Charleston, SC 29425-5290 United States
TEL	1-919-345-6001
Email	goldmr@musc.edu

Public contact
Name of contact person	Allison Anderson (Clinical Trial Manager)
Organization	Boston Scientific Corporation
Division name	Rhythm Management
Address	4100 Hamline Avenue North Arden Hills, MN 55126
TEL	1-919-345-6001
Homepage URL
Email	Allison.anderson@bsci.com

Sponsor
Institute	Boston Scientific Corporation Rhythm Management
Institute
Department

Funding Source
Organization	Boston Scientific Corporation Profit organization
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	USA

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

Secondary IDs
Secondary IDs	YES
Study ID_1	ClinicalTrials.gov Identifier: NCT03089281
Org. issuing International ID_1	ClinicalTrials.gov
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 06 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 01 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 06 Month 28 Day
Last modified on	2018 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036833