Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
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ClinicalTrials.gov Identifier: NCT02923726 |
Recruitment Status :
Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : August 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Sudden Cardiac Death | Device: Arm 1 (ATP+Shock) Device: Arm 2 (shock only) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP) |
Actual Study Start Date : | September 30, 2016 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
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Active Comparator: ATP and Shock
Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy.
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Device: Arm 1 (ATP+Shock)
Subjects will be randomized and device programmed to the respective arm. |
Experimental: Shock only
Once tachycardia has been detected and duration met, this group would receive shock therapy only.
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Device: Arm 2 (shock only)
Subjects will be randomized and device programmed to the respective arm. |
- Time-to-First All-Cause Shock [ Time Frame: From 60 days post implant up to five years ]Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up
- • All-cause mortality [ Time Frame: From 60 days post implant up to five years ]
- Time to first appropriate shock [ Time Frame: From 60 days post implant up to five years ]
- Time to first inappropriate shock [ Time Frame: From 60 days post implant up to five years ]

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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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 (≤ )30% OR
- Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35% , and a New York Heart Association (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
Exclusion Criteria:
- History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (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 ventricular assist device (VAD) or is to receive a 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923726

Principal Investigator: | Claudio Schuger, M.D. | University of Rochester Clincal Cardiovascular Research Center |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT02923726 |
Other Study ID Numbers: |
C1924 |
First Posted: | October 5, 2016 Key Record Dates |
Last Update Posted: | August 4, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Antitachycardia Pacing Therapy Shock Therapy Primary Prevention |
Death, Sudden, Cardiac Death Pathologic Processes Heart Arrest |
Heart Diseases Cardiovascular Diseases Death, Sudden |