Clinical Trials Logo
  1. Home
  2. Sudden Cardiac Death
  3. NCT00848835
  4. Details
NCT00848835 Clinical Trial

Long Term Integrity Follow-up Evaluation

Sudden Cardiac Death Clinical Trial

— LEAD LIFE  

Official title:
Long Term Integrity Follow-up Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00848835
Other study ID # LEAD LIFE
Secondary ID
Status Completed
Phase Phase 4
First received February 19, 2009
Last updated August 30, 2010
Start date March 2002
Est. completion date January 2010

Study information
Verified date August 2010
Source Guidant Corporation
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Description:

There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

Recruitment information / eligibility
Status Completed
Enrollment 372
Est. completion date January 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals

Exclusion Criteria:

- Patients enrolled in other studies, not available for follow-up, < 18 yrs, unable to sign consent, life expectancy < 1 year due to a medical condition

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• defibrillation lead (ENDOTAK EZ and RELIANCE)
defibrillation lead

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Guidant Corporation
See also
  Status Clinical Trial Phase
Completed NCT02923726 - Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP N/A
Recruiting NCT05175937 - REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
Completed NCT02026102 - A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs) N/A
Completed NCT01262508 - Development of Algorithms to Predict Hemodynamic Instability N/A
Completed NCT00998218 - Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV Dysfunction Phase 3
Completed NCT00845286 - Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial N/A
Active, not recruiting NCT00562757 - Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias N/A
Completed NCT00622453 - Arrhythmias in Myotonic Muscular Dystrophy N/A
Completed NCT03833843 - Sudden Cardiac Death in Systemic Right Ventricle
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05799833 - Low QRS Voltages in Young Healthy Individuals and Athletes
Recruiting NCT05694572 - Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Not yet recruiting NCT03622307 - Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death N/A
Recruiting NCT02056509 - The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation. N/A
Recruiting NCT02058771 - Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
Terminated NCT01948206 - Study of Paced QRS Duration as a Marker of Sudden Cardiac Death N/A
Completed NCT01227785 - Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study N/A
Terminated NCT00524862 - Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death N/A
Completed NCT00534300 - Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker Phase 1/Phase 2
Recruiting NCT00181233 - Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk