N/A N=215 Randomized Single-blind Other

Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead

Ventricular Tachycardia · Ventricular Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00180297 ↗

Enrolled (actual)

215

Serious AEs

32.1%

Results posted

Jul 2021

Primary outcome: Primary: Implant Success Rate at Septal Site — 97; 99 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Endotak Reliance G (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Sep 2012

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	—

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

Eligibility Criteria

Inclusion Criteria

ICD indication according to current Guidelines

Exclusion Criteria

Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency

View full record on ClinicalTrials.gov →

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.