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.
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.
Study Type
OBSERVATIONAL
Enrollment
994
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
The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
Time frame: 30 days post implant
360 Day S-ICD Complication Free Rate
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Time frame: Minimum 360 days post implant
Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT)
The number of subjects who received at least one inappropriate shock for SVT above the discrimination zone and SVT discriminator errors divided by the total implanted subjects.
Time frame: From enrollment to 5-year annual visit.
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Na Homolce Hospital
Prague, Prague 5, Czechia
Rigshospitalet
Copenhagen, København, Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
CHU La Timone
Marseille, France
Nouvelles Cliniques Nantaises
Nantes, France
Hôpital Cardiologique du Haut-L'évêque
Pessac, France
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Germany
...and 34 more locations