Unique ID issued by UMIN | UMIN000029382 |
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Receipt number | 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 15:02:15 |
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
(APPRAISE-ATP)
Japan | Asia(except Japan) | North America |
Europe |
Ventricular Tachycardia, Ventricular Fibrillation
Cardiology |
Others
NO
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.
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.
Time-to-First All-Cause Shock
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Treatment
Other |
1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized to ATP and shock
1:1 randomization will occur in the electronic data capture (EDC) system. Subjects will be randomized to shock only
20 | years-old | <= |
Not applicable |
Male and Female
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
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
2600
1st name | |
Middle name | |
Last name | Claudio Schuger, MD |
Henry Ford Health System
Cardiac Electrophysiology
2799 W Grand Blvd, M322 Detroit, MI 48202
+1-313-916-2417
cschuge1@hfhs.org
1st name | |
Middle name | |
Last name | Tina Cordaro |
Boston Scientific Corporation
Cardiac Rhythm Management
300 Boston Scientific Way Marlborough, MA 01752-1234
+1-585-330-6218
tina.cordaro@bsci.com
Boston Scientific Corporation
Boston Scientific Corporation
Profit organization
YES
ClinicalTrials.gov Identifier: NCT02923726
ClinicalTrials.gov
2017 | Year | 11 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 08 | Month | 02 | Day |
2016 | Year | 09 | Month | 01 | Day |
2017 | Year | 10 | Month | 02 | Day |
2017 | Year | 10 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033579
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