Arrhythmias & electrophysiology

Safety and performance of a novel implantable cardioverter defibrillator (ICD) lead for left bundle branch area pacing: Results from the ASCEND conduction system pacing (CSP) trial

Heart RhythmPublished prospective, multicenter, global, single arm, pivotal trial

Authors' conclusion

In this pivotal IDE trial, a dedicated bipolar CSP ICD lead demonstrated high implant success, stable electrical performance, reliable defibrillation efficacy, and favorable short-term safety. Longer-term follow-up is warranted to confirm durability and sustained clinical benefit.

Study context

Population
Patients undergoing de novo ICD or cardiac resynchronization therapy defibrillator (CRT-D) implantationimplant attempts, 202 patients (98.5%) had successful lead implantation
Participants
205 patients
Exposure
Compared with a pre-specified performance goal of 88% (safety) and a performance goal of 80% (effectiveness)
Outcome
Primary safety end point: freedom from lead-related serious adverse device effects (performance goal 88%); primary effectiveness end point: composite success rate of acceptable pacing capture threshold and R-wave sensing amplitude (performance goal 80%)
Follow-up
3 months
Methodological detailsInvestigational Device Exemption (IDE)
  • Investigational Device Exemption (IDE)

Main finding

As reported in the abstract

3-month major complication-free rate

97.5%

Primary effectiveness end point achieved

94.6%

Observational data: associations, not effects.

Further findings

Successful lead implantation

Patients with successful lead implantation, of 205 implant attempts
202 patients (98.5%)
Left bundle branch area pacing (LBBAP) criteria met
99.0%
Among these, LBBP or likely LBBP capture criteria met
86.0%

Defibrillation testing success (pre-specified cohort)

Defibrillation testing successful
100%
Defibrillated with a single 20 J shock
92.5%

Lead electrical performance · 3 months

Lead electrical performance remained stable through 3 months

Original publication

Safety and performance of a novel ICD lead for left bundle branch area pacing: Results from the ASCEND CSP trial. Heart Rhythm. Published 25 April 2026. doi:10.1016/j.hrthm.2026.03.1939

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