N/A
Completed N=215
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
Ventricular Tachycardia · ventricular fibrillation
Source: ClinicalTrials.gov NCT00180297 ↗
Enrolled (actual)
215
Serious AEs
32.1%
Results posted
Jul 2021
Primary outcomePrimary: Implant Success Rate at Septal Site — 97; 99 Participants
Summary
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Success Rate at Septal Site |
97; 99 | — |
| SECONDARY - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. |
0; 3; 1; 4; 2; 7 | — |
| SECONDARY The Rate of ATP Success Therapy |
6; 11; 12; 14; 19; 19 | — |
| SECONDARY Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment |
1; 2; 8; 11; 14; 17 | — |
| SECONDARY Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment |
0; 0; 4; 3; 3; 4 | — |
| SECONDARY Evolution of Left Ventricular Ejection Fraction |
41.96; 40.57; 5.66; 6.16 | — |
Eligibility Criteria
Inclusion Criteria
- ICD indication according to current Guidelines
Exclusion Criteria
- Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Data sourced from ClinicalTrials.gov (NCT00180297). 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.