Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ost-Alb Klinikum, Aalen, Germany

About this study

The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >=18 years
Signed written informed consent
Approved indication for implantation of ICD / CRT-D device

Exclusion criteria

Preexisting transvenous RV pacemaker or ICD leads
Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1)
Hypertrophic obstructive cardiomyopathy
Presence of intra-aortic balloon pump
Inotropic drug (not digitalis) necessary for hemodynamic support
Inability to perform VF induction testing due to anticipated high risk
Condition likely to limit cooperation
Unable to give informed consent
Pregnancy or planned pregnancy in the next 6 months
Patients with planned cardiac surgery within the next 3 months following randomization
Patient is currently participating in a clinical investigation that includes an active treatment arm.
Acute myocardial infarction within the previous 4 weeks.

Treatment and study plan

Device implantation

Device

ICD lead implantation

Other names: CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and, pacemaker- and active fixation ICD-leads

Primary outcomes

Event free survival of RV-ICD-lead related complications

Time frame: 3 months after implantation

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Septal Positioning of Ventricular ICD Leads

Acronym: SPICE

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2013
First posted: Sep 3, 2008
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed