N/A Completed N=305 Treatment

Electronic Repositioning With Acuity and Easytrak Leads

Heart Failure

Source: ClinicalTrials.gov NCT00610116 ↗

Enrolled (actual)

305

Serious AEs

13.7%

Results posted

Feb 2021

Primary outcomePrimary: Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU) — 94; 6 participants

Summary

Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) & success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)	94; 6	—

Eligibility Criteria

Inclusion Criteria

Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
Patients willing (= signed written consent) and capable to participate in all procedures of the study"

Exclusion Criteria

Patients who will not be available for routine Follow up
18 years old
Known pregnancy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00610116). 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. Informational only — not medical advice.