N/A
N=180
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
Ventricular Tachycardia (VT)
Bottom Line
View on ClinicalTrials.gov: NCT02848781 ↗Enrolled (actual)
180
Serious AEs
32.7%
Results posted
Dec 2022
Primary outcome: Primary: Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality — 33; 25; 28; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantable Cardioverter Defibrillator (ICD) (Device); Catheter Ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Recurrent VT, Cardiovascular Rehospitalization, and All-cause Mortality |
33; 25; 28; 27; 36; 19 | — |
| SECONDARY Freedom From Recurrent VT |
41; 30; 32; 19; 31; 15 | — |
| SECONDARY Freedom From Cardiovascular Rehospitalization |
43; 41; 35; 17; 20; 12 | — |
| SECONDARY Freedom From All-cause Mortality |
55; 57; 44; 5; 4; 3 | — |
Summary
The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy. These treatments are used to terminate the irregular heartbeats and bring the heart back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in addition to an ICD to treat their VT condition or risk of developing VT. This study aims to show that treating VT with catheter ablation, if performed preemptively at the time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.
Eligibility Criteria
Inclusion Criteria
- Patient is receiving a new implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy device (CRT-D) implant that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled.
- Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following:
- Spontaneous MMVT
- Inducible MMVT during electrophysiology study,
- Inducible MMVT during noninvasive programmed stimulation study *Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination (ATP or cardioversion)
- Patient has ejection fraction 3 months) outflow tract tachycardia
- Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2
- Patient has peripheral vascular disease that precludes left ventricular access
- Patient is thought to have idiopathic outflow VT as only VT
- Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
- Patient has reversible cause of VT
- Patient does not meet criteria for ICD or CRT-D
Data sourced from ClinicalTrials.gov (NCT02848781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.