NCT01085435

Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry

Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 994 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

Detailed description

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. An Extension Phase 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.

Conditions

• Tachycardia, Ventricular

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-02-02
• Primary completion: 2020-02-29
• Completion: 2024-01-01
• First posted: 2010-03-11
• Last updated: 2025-05-20
• Results posted: 2023-11-07

Locations

44 sites across 10 countries: Czechia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated device study