UltiSynq™ Defibrillation Lead

Built for Precise Positioning in the Left Bundle Branch Area

NEW Conduction System Pacing (CSP) ICD Lead Exceeds Primary Safety End Points in the ASCEND CSP IDE Study1

Left bundle branch area pacing (LBBAP) is an established conduction system pacing (CSP) strategy, but current practice often relies on adapting leads not designed for conduction system engagement.

A prospective, multicenter, global, single-arm study evaluated the safety and effectiveness of Abbott’s investigational CSP ICD lead in patients indicated for an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D).1 The primary safety endpoint was freedom from CSP ICD lead-related serious adverse effects and the primary effectiveness endpoint was a composite of acceptable pacing capture threshold and adequate R-wave sensing at 3 months, with defibrillation testing assessed in a prespecified cohort.

Among 205 implant attempts, lead implantation was successful in 98.5% of patients. LBBAP capture criteria were met in 99.0%, with left bundle branch pacing (LBBP) capture achieved in 86.0%. The 3-month major complication-free rate was 97.5%, exceeding the safety performance goal. The primary effectiveness endpoint was achieved in 94.6%, also surpassing the prespecified benchmark.1

Lead electrical performance remained stable through 3 months.

These results demonstrate high implant success, consistent conduction system engagement, and favorable short-term safety and electrical performance with a dedicated CSP ICD lead. The findings support the feasibility of purpose-built lead design for LBBAP, although longer-term follow-up is needed to assess durability and clinical outcomes.

The defibrillation threshold (DFT) testing was completed successfully in 120 patients without lead repositioning.1

DFT testing results
yielded a success rate of
100%

Of these 120 patients,
92.5% were
successfully defibrillated

with a single 20 J shock

MAT-2683119 v1.0