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

NCT01085435 | Completed Results DMC FDA Device

• 1 other identifier: 90904925; 90904928
• Study Type: observational
• Target: 994
• Locations: 10 countries
• Sites: 44

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.

Conditions

Tachycardia, Ventricular

Keywords

ICD; defibrillator

Outcome Measures

Primary Outcomes (3)

• 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

• 360 Day S-ICD Complication Free Rate

  The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.

  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.

  From enrollment to 5-year annual visit.

Other Outcomes (17)

• Extension Phase Rate of Long-term S-ICD System-related Adverse Events

  From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.

• Extension Phase S-ICD Replacements for Functionality

  From enrollment into the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.

• Extension Phase Device Longevity

  From enrollment in the Extension Phase up to 5 years until the 5th annual follow-up of the substudy, usually up to 60 months +/- 90 days.

Study Arms (2)

EFFORTLESS Main Study

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

Device: S-ICD System

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.

Device: S-ICD System

Interventions

S-ICD System 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.

Also known as: S-ICD Pulse Generator, S-ICD Subcutaneous Electrode, S-ICD Electrode Insertion Tool, S-ICD Programmer

EFFORTLESS Main Study; Extension Phase Sub Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post CE mark ICD patients eligible for implantation of the S-ICD system

You may qualify if:

• Age \>/= 18yrs
• 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)
• Willing and able to provide written informed consent or have informed consent as provided by a legal representative

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (44)

Na Homolce Hospital

Prague, Prague 5, 15030, Czechia

Location

Rigshospitalet

Copenhagen, København, 2100, Denmark

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

CHU La Timone

Marseille, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

Hôpital Cardiologique du Haut-L'évêque

Pessac, France

Location

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, Germany

Location

Klinikum Bielefeld

Bielefeld, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

University Hospital Schleswig-Holstein

Lübeck, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Ludwig-Maximilians-Universität München, Campus Großhadern

Munich, 81377, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Marienkrankenhaus Papenburg

Papenburg, Germany

Location

Arnas Garibaldi Nesima

Catania, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

Azienda Ospedaliero Universitaria Padova

Padua, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Policlinico Casilino

Rome, Italy

Location

Maastricht University Medical Center

Maastricht, AZ Maastricht, 6202, Netherlands

Location

Catharina Eindhoven Hospital

Eindhoven, EJ Eindhoven, 5623, Netherlands

Location

Amsterdam Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

Location

University Medical Center Groningen

Groningen, 9713, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Hospital Santa Cruz

Carnaxide, Portugal

Location

Complexo Hospitalario Universitario

A Coruña, Spain

Location

Papworth Hospital

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Leeds General Infirmary

Leeds, Yorkshire, LS1 1YY, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Russells Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

Yorkhill Children's Hospital

Glasgow, G3 8SJ, United Kingdom

Location

Yorkshire Heart Centre

Leeds, United Kingdom

Location

St. Bartholomew's Hospital

London, W1G 8SE, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Southampton General

Southampton, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 28797351 DERIVED

• 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.

  PMID: 25908064 DERIVED

• 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.

  PMID: 24670710 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jens Goetzke
• Organization: Boston Scientific

jens.goetzke@bsci.com

1-800-227-3422

Study Officials

• Pier Lambiase, Prof.

  St. Bartholomew's Hospital, London

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: February 2, 2011
• Primary Completion: February 29, 2020
• Study Completion: January 1, 2024
• Last Updated: May 20, 2025
• Results First Posted: November 7, 2023

Record last verified: 2024-11

Locations

GB (12); NZ (1); NL (7); FR (3); IT (5); PT (1); DK (4); ES (1); DE (9); CZ (1)