UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015371
Receipt number R000017460
Scientific Title AdaptResponse Clinical Study
Date of disclosure of the study information 2014/10/09
Last modified on 2023/09/21 22:00:47

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Basic information

Public title

AdaptResponse Clinical Study

Acronym

AdaptResponse Clinical Study

Scientific Title

AdaptResponse Clinical Study

Scientific Title:Acronym

AdaptResponse Clinical Study

Region

Japan Asia(except Japan) North America
South America Australia Europe


Condition

Condition

Heart Failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

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 left bundle branch block.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of the combined endpoint of all-cause mortality and intervention for heart failure decompensation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

18 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 indicated for a CRT device according to local guidelines.
3,Subject has, minimally:
o Sinus Rhythm at time of enrollment.
o Left Bundle Branch Block (LBBB) as
documented on an ECG. Criteria for
complete LBBB must include:
*Intrinsic QRS duration
More than140ms(men) or 130ms(women)
*QS or rS in leads V1 and V2,
*Mid-QRS notching or slurring in
*2 leads V1, V2, V5, V6, I, aVL.
o Intrinsic, normal AV conduction as
documented on an ECG by a PR
interval less than or equal to 200ms.
o Left ventricular ejection fraction
less than or equal to 35%.
o NYHA class II, 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 is less than 18 years of age.
2,Subject is not expected to remain available for at least 2 years of follow-up visits.
3,Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
4,Subject is, or previously has been, receiving CRT.
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 is post heart transplant.
9,Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
10,Subject is pregnant.
11,Subject meets any exclusion criteria required by local law.

Target sample size

3500


Research contact person

Name of lead principal investigator

1st name Janelle
Middle name
Last name van Wel

Organization

Medtronic Bakken Research Center

Division name

CRM Clinical Research

Zip code

NA

Address

Endepolsdomein 5, 6229 GW Maastricht, Nederland

TEL

310433566634

Email

janelle.van.wel@medtronic.com


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Sekiguchi

Organization

Medtronic Japana Co., Ltd.

Division name

Operation Unit Clinical, Japan Clinical and Medical Affairs

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku,Tokyo, Japan

TEL

03-6774-4611

Homepage URL


Email

hideaki.sekiguchi@medtronic.com


Sponsor or person

Institute

Medtronic Japana Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Medtronic Japana Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Certified Review Board of Hyogo Medical University

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501, Hyogo

Tel

0798-45-6066

Email

rinken@hyo-med.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02205359

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

jRCTs052180128

Org. issuing International ID_2

Japan Registry of Clinical Trials

IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

3800

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 08 Month 25 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 09 Month 26 Day

Anticipated trial start date

2014 Year 11 Month 10 Day

Last follow-up date

2023 Year 11 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 08 Day

Last modified on

2023 Year 09 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017460


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name