Boston Scientific Post Market S-ICD Registry (EFFORTLESS)
|ClinicalTrials.gov Identifier: NCT01085435|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2010
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment|
|Tachycardia, Ventricular||Device: S-ICD System|
EFFORTLESS is an observational, post market, standard of care, Registry to be conducted at approximately 50 centers worldwide in patients requiring an ICD for the treatment of ventricular tachyarrhythmias. Patients included in the registry will have been implanted with the S-ICD system since its CE mark (commercial regulatory approval) and will be followed for up to 60 months. The patients' perception of their therapy will be evaluated using Quality of Life assessments and the Registry will include an exploratory analysis of resource utilization and costs based on measures of clinical outcome such as complication rates, unscheduled hospitalizations and length of stay. The objective will be to enable comparison of costs of the S-ICD system versus a standard transvenous system.
A Sub-Study will extend the EFFORTLESS S-ICD Registry in order to achieve an average of approximately 8 years of follow-up from index procedure. A subgroup of approximately 200 patients will be enrolled at a sub-set of EFFORTLESS sites. The data analysis will focus on long-term S-ICD system-related adverse events, S-ICD replacements and device longevity.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)|
|Actual Study Start Date :||October 2010|
|Estimated Primary Completion Date :||November 24, 2019|
|Estimated Study Completion Date :||December 2023|
U.S. FDA Resources
S-ICD System Commercial Patients
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
Device: S-ICD System
The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
- Perioperative S-ICD Complication Free Rate [ Time Frame: 30 days post implant ]
- 360 Day S-ICD Complication Free Rate [ Time Frame: Minimum 360 days post implant ]
- Percentage of inappropriate shocks for AF/SVT [ Time Frame: Study duration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085435
Show 45 Study Locations
|Study Chair:||Pier Lambiase, Prof.||St. Bartholomew's Hospital, London|