Tachycardia, Ventricular Clinical Trial
— EFFORTLESSOfficial title:
Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
Verified date | June 2024 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 994 |
Est. completion date | January 2024 |
Est. primary completion date | February 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Main study: Inclusion Criteria 1. Age >/= 18yrs 2. Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD system (SW version 1.59.0 or later) 3. Willing and able to provide written informed consent or have informed consent as provided by a legal representative Exclusion Criteria: 1. Participation in any other investigational study that may interfere with interpretation of the Registry results 2. Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing 3. Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing Extension Phase Sub-study: Inclusion Criteria 1. 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. 2. 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 3. 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 4. Age 18 or above, and of legal age to give informed consent specific to national laws Exclusion Criteria 1. Subjects with device replacement from the S-ICD to a transvenous ICD 2. Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing 3. 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Na Homolce Hospital | Prague | Prague 5 |
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Rigshospitalet | Copenhagen | København |
Denmark | Odense University Hospital | Odense | |
France | CHU La Timone | Marseille | |
France | Nouvelles Cliniques Nantaises | Nantes | |
France | Hôpital Cardiologique du Haut-L'évêque | Pessac | |
Germany | Universitäts-Herzzentrum Freiburg-Bad Krozingen | Bad Krozingen | |
Germany | Immanuel Klinikum Bernau Herzzentrum Brandenburg | Bernau | |
Germany | Klinikum Bielefeld | Bielefeld | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | University Hospital Schleswig-Holstein | Lübeck | |
Germany | Universitätsmedizin Mannheim | Mannheim | |
Germany | Ludwig-Maximilians-Universität München, Campus Großhadern | Munich | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Marienkrankenhaus Papenburg | Papenburg | |
Italy | Arnas Garibaldi Nesima | Catania | |
Italy | Ospedale Sacro Cuore Don Calabria | Negrar | |
Italy | Azienda Ospedaliero Universitaria Padova | Padova | |
Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
Italy | Policlinico Casilino | Rome | |
Netherlands | Amsterdam Medisch Centrum | Amsterdam | |
Netherlands | Catharina Eindhoven Hospital | Eindhoven | EJ Eindhoven |
Netherlands | Medisch Spectrum Twente | Enschede | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Maastricht University Medical Center | Maastricht | AZ Maastricht |
Netherlands | St Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Erasmus Medical Center | Rotterdam | |
New Zealand | Auckland City Hospital | Auckland | |
Portugal | Hospital Santa Cruz | Carnaxide | |
Spain | Complexo Hospitalario Universitario | A Coruña | |
United Kingdom | Royal Sussex County Hospital | Brighton | |
United Kingdom | Bristol Royal Infirmary | Bristol | |
United Kingdom | Papworth Hospital | Cambridge | Cambridgeshire |
United Kingdom | Russells Hall Hospital | Dudley | |
United Kingdom | Yorkhill Children's Hospital | Glasgow | |
United Kingdom | Leeds General Infirmary | Leeds | Yorkshire |
United Kingdom | Yorkshire Heart Centre | Leeds | |
United Kingdom | Kings College Hospital | London | |
United Kingdom | St. Bartholomew's Hospital | London | |
United Kingdom | John Radcliffe Hospital | Oxford | |
United Kingdom | Northern General Hospital | Sheffield | |
United Kingdom | Southampton General | Southampton |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
Czechia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Portugal, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 days post implant | |
Primary | 360 Day S-ICD Complication Free Rate | The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications. | Minimum 360 days post implant | |
Primary | Percentage of Inappropriate Shocks for AF/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. | From enrollment to 5-year annual visit. |
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