UMIN-CTR Clinical Trial

Public title

Adoption of Adaptive CRT in Patients with LBBB and Moderate Wide QRS

Acronym

aCRT MID-Q

Scientific Title

Adoption of Adaptive CRT in Patients with LBBB and Moderate Wide QRS

Scientific Title:Acronym

aCRT MID-Q

Region

Japan

Condition

heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this clinical study is to test the hypothesis that CRT devices with AdaptivCRT(aCRT) algorithm
have a superior outcome compared to standard CRT devices in CRT indicated patients with normal AV conduction and moderately wide left bundle branch block.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical composite score at 6 months follow-up

Key secondary outcomes

Change in left ventricular end-systolic volume
Change in left ventricular ejection fraction
Changes in NYHA functional class
Changes in 6-minute hall walk test
Changes in scores of Minnesota living with heart failure quality of life assessment
Time to first heart failure hospitalization
Time to all death and cardiovascular death

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

Device,equipment

Interventions/Control_1

Treatment Arm: aCRT ON

Interventions/Control_2

Control Arm: aCRT OFF

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

(1)Subject is willing to sign and date the study patient informed consent form.
(2)Subject is 20 years old and over.
(3),Subject is expected to remain available for at least 6 months of follow-up visits.
(4)Subject is indicated for a CRT device according to local guidelines within 60 days after writing the informed consent form.
(5)Subject has,
o Sinus Rhythm with preserved AV conduction at time of enrollment.
o moderately wide left bundle branch block (LBBB)as documented on an ECG.
o Left ventricular ejection fraction
less than or equal to 35%.
o NYHA class III or IV despite
optimal medical therapy.
Optimal medical therapy is defined
as maximal tolerated dose of Beta-
blockersand a therapeutic dose of
ACE-I, ARB or Aldosterone Antagonist.

Key exclusion criteria

(1)Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
(2)Subject is, or previously has been,
receiving CRT.
(3)Subject has a previously implanted lead with damage or unstable measurement value.
(4)Subject already has medical condition which may limit the participation to the trial.
(5)Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study.
(6)Subject has unstable angina, or experienced an acute myocardial infarction or received coronary artery revascularization or coronary angioplasty within 30 days prior to enrollment.
(7)Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
(8)Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
(9)Subject is pregnant.
(10)Subject meets any exclusion criteria by research representative.

Target sample size

260

Name of lead principal investigator

1st name	Kazutaka
Middle name
Last name	Aonuma

Organization

University of Tsukuba, Faculty of Medicine

Division name

Cardiovascular Division

Zip code

305-8576

Address

1-1-1, Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3142

Email

kaonuma@md.tsukuba.ac.jp

Name of contact person

1st name	Hiro
Middle name
Last name	Yamasaki

Organization

University of Tsukuba, Faculty of Medicine

Division name

Cardiovascular Division

Zip code

3058576

Address

1-1-1, Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3142

Homepage URL

Email

hyamasaki@md.tsukuba.ac.jp

Institute

University of Tsukuba, Faculty of Medicine, Cardiovascular Division

Institute

Department

Personal name

Organization

Medtronic Japana Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

T-CReDO

Address

2-1-1 Amakubo, Tsukuba, Ibaraki, Japan

Tel

029-853-3914

Email

t-credo.adm@un.tsukuba.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

01

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

Terminated

Date of protocol fixation

2016

Year

05

Month

20

Day

Date of IRB

2016

Year

06

Month

01

Day

Anticipated trial start date

2016

Year

07

Month

01

Day

Last follow-up date

2018

Year

09

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

25

Day

Last modified on

2019

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025824