CONTEMP-ICD

Inclusion

• Age ≥ 18 years (no upper limit).
• Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%.
• Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT for at least one month.
• Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization: 
  • Receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR
  • GDMT Score ≥ 6.
• MADIT-ICD Benefit Score < 50.

Exclusion

• Existing ICD/CRT-D.
• Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications.
•  Acute MI within the past 3 calendar months.
• Chronic renal failure requiring hemodialysis.
• Coronary revascularization within the past 3 calendar months.
• History of sustained VT or VF.
• Known genetic cause of cardiomyopathy.
• Life expectancy < 1 year.
• Unable or unwilling to follow study protocol.
• Inability to consent.