UMIN-CTR Clinical Trial

Public title

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy

Acronym

SMART CRT

Scientific Title

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy

Scientific Title:Acronym

SMART CRT

Region

Japan	North America	Europe

Condition

Heart Failure, Ventricular Tachycardia, Ventricular Fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Michael Gold

Organization

Medical University of South Carolina

Division name

Division of Cardiology

Zip code

Address

114 Doughty Street MSC 592 Charleston, SC 29425-5290 United States

TEL

1-919-345-6001

Email

goldmr@musc.edu

Name of contact person

1st name
Middle name
Last name	Allison Anderson (Clinical Trial Manager)

Organization

Boston Scientific Corporation

Division name

Rhythm Management

Zip code

Address

4100 Hamline Avenue North Arden Hills, MN 55126

TEL

1-919-345-6001

Homepage URL

Email

Allison.anderson@bsci.com

Institute

Boston Scientific Corporation
Rhythm Management

Institute

Department

Personal name

Organization

Boston Scientific Corporation
Profit organization

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

USA

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2018

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

04

Month

10

Day

Date of IRB

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

Other related information

Registered date

2018

Year

06

Month

28

Day

Last modified on

2018

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036833