UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029382 |
|---|---|
| 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 | 2024/10/24 08:08:20 |
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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 | Claudio |
| Middle name | |
| Last name | Schuger, MD |
Organization
Henry Ford Health System
Division name
Cardiac Electrophysiology
Zip code
48202
Address
2799 W Grand Blvd, M322 Detroit, MI
TEL
+1-313-916-2417
cschuge1@hfhs.org
Public contact
Name of contact person
| 1st name | Tina |
| Middle name | |
| Last name | Cordaro |
Organization
Boston Scientific Corporation
Division name
Cardiac Rhythm Management
Zip code
01752-1234
Address
300 Boston Scientific Way Marlborough, MA
TEL
+1-585-330-6218
Homepage URL
tina.cordaro@bsci.com
Sponsor or person
Institute
Boston Scientific Corporation
Institute
Department
Personal name
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
Henry Ford Health System
Address
Henry Ford Health System Research Administration 1 Ford Place -2F Detroit, MI 48202-2689
Tel
+1-313-874-4464
NA
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
https://jamanetwork.com/journals/jama/fullarticle/2824425
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jama/fullarticle/2824425
Number of participants that the trial has enrolled
2626
Results
The use of a single burst of ATP prior to shock in primary prevention ICD recipients with modern ICD detection programming prolonged the time to first all-cause ICD shock.
Results date posted
| 2024 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 03 | Day |
Baseline Characteristics
A total of 2595 patients were randomized (mean age, 63.9 years; 22.4%were females).
The main clinical characteristics at baseline were similar in both groups.
Participant flow
Between September 2016 and April 2021, a total of 2626 patients were enrolled at 134 centers in North America, Europe, and Asia. Of these patients, 2595 patients underwent randomization. 1302 were randomized to the ATP plus shock group and 1293 were randomized to the shock only group. The main clinical characteristics at baseline were similar in both groups. The median follow-up was 38 months in the ATP plus shock group and 41 months in the shock only group. The annual withdrawal rate was 7.5%. A total of 644 patients were withdrawn before completion of the study. Of these patients, 73 withdrew from the study after reaching the primary end point. There was no significant difference in withdrawals between randomization groups. The annual withdrawal rate differed by 1.1% from pre- to post-COVID-19 periods (before and after January 31, 2020, 6.7% vs 7.8%). A withdrawal sensitivity analysis indicated minimal expected impact on the primary end point.
Adverse events
All adverse events and serious adverse events were reported.
Outcome measures
A total of 2595 patients were randomized (mean age, 63.9 years; 22.4%were females). At a mean follow-up of 38 months, first all-cause shock occurred in 129 participants in the ATP plus shock group and 178 participants in the shock only group. The hazard ratio
(HR) for the primary end point was 0.72 (95.9%CI, 0.57-0.92), with P = .005 for superiority of the ATP plus shock group over the shock only group. During follow-up in an intention-to-treat analysis, the total shock burden per 100 patient-years was not statistically
different, at 12.3 and 14.9, respectively (P = .70).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 06 | Day |
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
| 2024 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033579
