Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
- Conditions
- Tachycardia, Ventricular
- Interventions
- Device: S-ICD System
- Registration Number
- NCT01085435
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 994
Not provided
- Participation in any other investigational study that may interfere with interpretation of the Registry results
- Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Extension Phase Sub-study:
Inclusion Criteria
- Subjects who are actively enrolled in the EFFORTLESS S-ICD Registry OR Subjects who completed the 5-year follow-up in the EFFORTLESS S-ICD Registry. All clinical events, spontaneous and induced episode data and system replacement or revision data since the last EFFORTLESS S-ICD Annual Follow-Up of the main study must be available in medical files or equivalent.
- Subjects who are actively implanted with an S-ICD pulse generator (SQ-RX, EMBLEM or EMBLEM MRI) and an S-ICD electrode (Q-TRAK or EMBLEM) or any other future commercial available versions
- Willing and able to provide written informed consent or have informed consent as provided by a legal representative and willing to participate in all testing and follow-ups as described the Sub-Study protocol
- Age 18 or above, and of legal age to give informed consent specific to national laws
Exclusion Criteria
- Subjects with device replacement from the S-ICD to a transvenous ICD
- Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing
- Subjects that are participating in any other investigational study that may interfere with interpretation of the Registry results, without the written approval of Boston Scientific
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Extension Phase Sub Study S-ICD System The Sub-Study patients were preferably recruited from the active EFFORTLESS S-ICD patient population. Patients, who had already completed the EFFORTLESS S-ICD Registry in the past, were considered secondarily for participation in the Sub-Study. EFFORTLESS Main Study S-ICD System Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
- Primary Outcome Measures
Name Time Method Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT) From enrollment to 5-year annual visit. 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.
Perioperative S-ICD Complication Free Rate 30 days post implant The number of subjects without Type I Complications within 30 Days of Implant divided by the Total Implanted Subjects.
360 Day S-ICD Complication Free Rate Minimum 360 days post implant The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Odense University Hospital
🇩🇰Odense, Denmark
CHU La Timone
🇫🇷Marseille, France
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Rigshospitalet
🇩🇰Copenhagen, København, Denmark
Na Homolce Hospital
🇨🇿Prague, Prague 5, Czechia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
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
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum Bielefeld
🇩🇪Bielefeld, Germany
University Hospital Schleswig-Holstein
🇩🇪Lübeck, Germany
Ludwig-Maximilians-Universität München, Campus Großhadern
🇩🇪Munich, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Marienkrankenhaus Papenburg
🇩🇪Papenburg, Germany
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Arnas Garibaldi Nesima
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Padova
🇮🇹Padova, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Maastricht University Medical Center
🇳🇱Maastricht, AZ Maastricht, Netherlands
Catharina Eindhoven Hospital
🇳🇱Eindhoven, EJ Eindhoven, Netherlands
Policlinico Casilino
🇮🇹Rome, Italy
Amsterdam Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Complexo Hospitalario Universitario
🇪🇸A Coruña, Spain
Leeds General Infirmary
🇬🇧Leeds, Yorkshire, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
Yorkshire Heart Centre
🇬🇧Leeds, United Kingdom
Yorkhill Children's Hospital
🇬🇧Glasgow, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Southampton General
🇬🇧Southampton, United Kingdom
Hospital Santa Cruz
🇵🇹Carnaxide, Portugal
Papworth Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom