Clinical Trials Logo
  1. Home
  2. Ventricular Tachycardia
  3. NCT00745745
  4. Details
NCT00745745 Clinical Trial

Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

Ventricular Tachycardia Clinical Trial

— SPICE  

Official title:
Septal Positioning of Ventricular ICD Leads

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00745745
Other study ID # T83
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2008
Est. completion date January 2013

Study information
Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date January 2013
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Device Implantation
ICD lead implantation

Locations
Country Name City State
Germany Ost-Alb Klinikum Aalen
Germany SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald Bad Friedrichshall
Germany Segeberger Kliniken GmbH Bad Segeberg
Germany Städtisches Klinikum Brandenburg Brandenburg
Germany Medizinisches Versorgungszentrum Dachau
Germany Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen Düren
Germany Klinikum Esslingen Esslingen
Germany Universitätsklinik Freiburg Freiburg
Germany Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH Göttingen
Germany Asklepios Klinik St. Georg Hamburg
Germany Oberhavel Kliniken GmbH Klinik Hennigsdorf Hennigsdorf
Germany Krankenhaus Landshut-Achdorf Landshut
Germany Universitätsklinikum Leipzig AÖR Leipzig
Germany Kliniken Ludwigsburg-Bietigheim Ludwigsburg
Germany Märkische Kliniken GmbH Klinikum Lüdenscheid Luedenscheid
Germany Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg Mannheim
Germany Maria-Hilf Franziskus-Krankenhaus Mönchengladbach
Germany Deutsches Herzzentrum Muenchen Munich
Germany Niels-Stensen-Kliniken Marienhospital Osnabrück Osnabrück
Germany Klinkum Peine gGmbH Peine
Greece Henry Dunant Hospital Athens

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event free survival of RV-ICD-lead related complications 3 months after implantation
See also
  Status Clinical Trial Phase
Recruiting NCT03453645 - Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Completed NCT04011631 - Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Enrolling by invitation NCT02962076 - Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia Early Phase 1
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01791543 - Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia N/A
Terminated NCT02891863 - Low Energy Therapy to Convert Ventricular Tachycardias Phase 0
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT01294267 - Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation N/A
Terminated NCT00383799 - Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT04642963 - Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia N/A
Recruiting NCT05377216 - Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation Early Phase 1
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Completed NCT04065893 - Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Recruiting NCT03631303 - Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Recruiting NCT03611465 - Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts N/A