APPRAISE ATP_Post Market Trial (0393-0021)
Research type
Research Study
Full title
Assessment of Primary Prevention Patients Receiving An ICD – Systematic Evaluation of ATP
IRAS ID
220156
Contact name
Pier David Lambiase
Contact email
Sponsor organisation
Boston Scientific, Rhythm Management (RM)
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 20 days
Research summary
APPRAISE ATP is a global, prospective, randomised, multi-centre clinical trial that has been classified as a non-mandated post market trial.
Implantable cardioverter defibrillators (ICD’s) are designed to keep track of a patient’s heart rate and stop fast heart rhythms that may become life-threatening. ICD devices allow the heart to return to a stable, regular heart rhythm by applying an electrical shock to the heart.
The APPRAISE ATP study is designed to assess the incidence of all cause shocks in patients who have an indication for primary prevention of sudden cardiac death and a low ejection fraction that are implanted with a commercially approved Boston Scientific single and dual chamber transvenous ICD (TV-ICD).
The study is intended to determine the value of ATP in this patient population utilising current programming guidelines of higher rates and longer delays. Patients will be randomised to ATP (Anti-tachycardia pacing) and shock, or shock only.
All implanted devices will be used within the current labelled indications for use in the applicable geography.
Approximately 2,600 patients will be enrolled in this trial at up to 200 sites globally. 1:1 randomisation will occur in the electronic data capture (EDC) system. The trial duration is estimated to be 5.5 years from 1st enrolment to study closure. Patients will be followed through 60 months (5 years). Their length of participation will differ depending when they entered the study. Sites will continue to follow up patients until notified of follow-up completion.
The data collection schedule for this study is aligned with standard of care (SOC) practices at centres. Therefore, there are two data collection schedules for patients:
1) Patients who are not monitored on LATITUDE, a remote monitoring method and
2) Patients who are monitored on LATITUDE.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0662
Date of REC Opinion
22 Mar 2018
REC opinion
Further Information Favourable Opinion