Table 1.

Inclusion and exclusion criteria

Inclusion criteria

•Class I, IIa, or IIb guideline ICD indications,7, 16 or an existing TV-ICD∗ or S-ICD† • At risk for MVT based on history of at least ONE of: o Nonsustained MVT with LVEF ≤50% ○ Sustained VA (secondary prevention) with LVEF ≤50% or significant cardiac scar‡ ○ Syncope of arrhythmic origin ○ Ischemic cardiomyopathy with LVEF ≤35% ○ Nonischemic cardiomyopathy with LVEF ≤35% and significant scar‡ •Able to undergo study requirements •18 years (or older, if required by local law)

Exclusion criteria

•Ongoing complication due to CIED infection or CIED explantation •Transvenous lead remnants within heart from previously implanted CIED •Known LA thrombus •Ventricular arrhythmia due to reversible cause •Indicated for dual chamber pacemaker or cardiac resynchronization therapy •Implanted medical device that could interfere with leadless pacemaker implant •Requires rate-responsive pacing •Pacemaker-dependent (escape rhythm ≤30 beats/min) •Acute coronary syndrome within 40 days •Inability to access femoral vein with ≥21F inner diameter introducer sheath •Active implanted electronic medical device intended for chronic use •Sensitivity to dexamethasone acetate •Cardiovascular anatomy that precludes right ventricular implantation •Allergy to any system components •Intolerance to S-ICD conversion testing •Life expectancy <12 months •Enrollment in concurrent confounding study •Pregnant/breastfeeding woman

MVT was defined as ventricular tachycardia >30 seconds.

CIED = cardiac implantable electronic device; LA = left atrial; LVEF = left ventricular ejection fraction; MI = myocardial infarction; MVT = monomorphic ventricular tachycardia; S-ICD = subcutaneous implantable cardioverter-defibrillator; TV-ICD = transvenous implantable cardioverter-defibrillator; VA = ventricular arrhythmia.

^∗TV-ICD system is expected to be fully explanted during or prior to full system implantation.

^†Patients with Model 1010 S-ICD or subject to electrical overstress field action are eligible if upgraded to BSC Model A209 or A219, or future BSC S-ICD Pulse Generator.

^‡A scar involving at least 1 ventricular myocardial segment.