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
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
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
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
