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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029382
Receipt No. R000033579
Scientific Title Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE-ATP)
Date of disclosure of the study information 2017/11/01
Last modified on 2017/10/02

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Basic information
Public title Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Acronym Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Scientific Title Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Scientific Title:Acronym Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Region
Japan Asia(except Japan) North America
Europe

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

Objectives
Narrative objectives1 The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy. The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency.
Basic objectives2 Others
Basic objectives -Others The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time-to-First All-Cause Shock
Key secondary outcomes Time-to-First All-Cause Shock or Death from Any Cause
Time-to-Death from Any Cause
Time-to-First Appropriate Shock
Time-to-First Inappropriate Shock

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
Other
Interventions/Control_1 1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized to ATP and shock
Interventions/Control_2 1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized to shock only
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 with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD ) implanted because of one of the following:
Prior MI and left ventricular ejection fraction (LVEF) less than or equal to (< or)30% OR
Ischemic or non-ischemic cardiomyopathy, and LVEF < or 35% , and NYHA class II or III
Subject is age 21or above, or is considered of legal age per given geography
Subject is willing and capable of providing informed consent
Subject is willing and capable of complying with follow-up visits as defined by this protocol
Key exclusion criteria History of spontaneous sustained VT (> or 160 bpm at > or 30 seconds in duration) or VF not due to a reversible cause
NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
Subjects with a previous subcutaneous ICD (S-ICD)
Subject with existing TV-ICD device implanted for greater than 60 days
Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
Subjects on the active heart transplant list
Subject who has a VAD or is to receive VAD
Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...)
Subjects currently requiring hemodialysis
Subject who is known to pregnant or plans to become pregnant over the course of the trial
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
Target sample size 2600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Claudio Schuger, MD
Organization Henry Ford Health System
Division name Cardiac Electrophysiology
Zip code
Address 2799 W Grand Blvd, M322 Detroit, MI 48202
TEL +1-313-916-2417
Email cschuge1@hfhs.org

Public contact
Name of contact person
1st name
Middle name
Last name Tina Cordaro
Organization Boston Scientific Corporation
Division name Cardiac Rhythm Management
Zip code
Address 300 Boston Scientific Way Marlborough, MA 01752-1234
TEL +1-585-330-6218
Homepage URL
Email tina.cordaro@bsci.com

Sponsor
Institute Boston Scientific Corporation
Institute
Department

Funding Source
Organization Boston Scientific Corporation
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 ClinicalTrials.gov Identifier: NCT02923726
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
2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033579

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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