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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01085435
Other study ID # 90904925; 90904928
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2011
Est. completion date January 2024

Study information

Verified date June 2024
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Czechia,  Denmark,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Portugal,  Spain,  United Kingdom, 

Outcome

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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