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

NCT ID: NCT01085435

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 994 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-02
• Study Completion Date: 2024-01-31

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.

Conditions

Tachycardia, Ventricular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EFFORTLESS Main Study

Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.

S-ICD System

Intervention Type: DEVICE

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.

Extension Phase Sub Study

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.

S-ICD System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

S-ICD Pulse Generator; S-ICD Subcutaneous Electrode; S-ICD Electrode Insertion Tool; S-ICD Programmer

Eligibility Criteria

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 (Software (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

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. 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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pier Lambiase, Prof.

Role: STUDY_CHAIR

St. Bartholomew's Hospital, London

Locations

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

Klinikum Bielefeld

Bielefeld, , Germany

Medizinische Hochschule Hannover

Hanover, , 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, , Germany

Arnas Garibaldi Nesima

Catania, , Italy

Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Azienda Ospedaliero Universitaria Padova

Padua, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Policlinico Casilino

Rome, , Italy

Maastricht University Medical Center

Maastricht, AZ Maastricht, Netherlands

Catharina Eindhoven Hospital

Eindhoven, EJ Eindhoven, Netherlands

Amsterdam Medisch Centrum

Amsterdam, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Hospital Santa Cruz

Carnaxide, , Portugal

Complexo Hospitalario Universitario

A Coruña, , Spain

Papworth Hospital

Cambridge, Cambridgeshire, United Kingdom

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

Yorkhill Children's Hospital

Glasgow, , United Kingdom

Yorkshire Heart Centre

Leeds, , United Kingdom

St. Bartholomew's Hospital

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Southampton General

Southampton, , United Kingdom

Countries

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

References

Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.

Reference Type: DERIVED

PMID: 28797351 (View on PubMed)

Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.

Reference Type: DERIVED

PMID: 25908064 (View on PubMed)

Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kaab S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

Reference Type: DERIVED

PMID: 24670710 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

90904925; 90904928

Identifier Type: -

Identifier Source: org_study_id