N/A
N=305
Electronic Repositioning With Acuity and Easytrak Leads
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00610116 ↗Enrolled (actual)
305
Serious AEs
13.7%
Results posted
Feb 2021
Primary outcome: 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 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic Repositioning (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2008
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 | — |
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
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.
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.