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

Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

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.

Study Overview

• Status: Completed
• Conditions: Tachycardia, Ventricular
• Intervention / Treatment: Device: S-ICD System

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.

• Study Type: Observational
• Enrollment (Actual): 994

Contacts and Locations

Study Locations

• Czechia
  • Prague 5
    • Prague, Prague 5, Czechia, 15030
      • Na Homolce Hospital
• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
  • København
    • Copenhagen, København, Denmark, 2100
      • Rigshospitalet
• France
  • Marseille, France
    • CHU La Timone
  • Nantes, France
    • Nouvelles Cliniques Nantaises
  • Pessac, France
    • Hôpital Cardiologique du Haut-L'évêque
• Germany
  • Bad Krozingen, Germany
    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Bernau, Germany
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Bielefeld, Germany
    • Klinikum Bielefeld
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Lübeck, Germany
    • University Hospital Schleswig-Holstein
  • Mannheim, Germany
    • Universitätsmedizin Mannheim
  • Munich, Germany, 81377
    • Ludwig-Maximilians-Universität München, Campus Großhadern
  • Münster, Germany
    • Universitatsklinikum Munster
  • Papenburg, Germany
    • Marienkrankenhaus Papenburg
• Italy
  • Catania, Italy
    • Arnas Garibaldi Nesima
  • Negrar, Italy
    • Ospedale Sacro Cuore Don Calabria
  • Padova, Italy
    • Azienda Ospedaliero Universitaria Padova
  • Pisa, Italy
    • Azienda Ospedaliero Universitaria Pisana
  • Rome, Italy
    • Policlinico Casilino
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam Medisch Centrum
  • Enschede, Netherlands, 7513 ER
    • Medisch Spectrum Twente
  • Groningen, Netherlands, 9713
    • University Medical Center Groningen
  • Nieuwegein, Netherlands, 3430 EM
    • St Antonius Ziekenhuis
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medical Center
  • AZ Maastricht
    • Maastricht, AZ Maastricht, Netherlands, 6202
      • Maastricht University Medical Center
  • EJ Eindhoven
    • Eindhoven, EJ Eindhoven, Netherlands, 5623
      • Catharina Eindhoven Hospital
• New Zealand
  • Auckland, New Zealand, 1142
    • Auckland City Hospital
• Portugal
  • Carnaxide, Portugal
    • Hospital Santa Cruz
• Spain
  • A Coruña, Spain
    • Complexo Hospitalario Universitario
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Royal Infirmary
  • Dudley, United Kingdom, DY1 2HQ
    • Russells Hall Hospital
  • Glasgow, United Kingdom, G3 8SJ
    • Yorkhill Children's Hospital
  • Leeds, United Kingdom
    • Yorkshire Heart Centre
  • London, United Kingdom
    • Kings College Hospital
  • London, United Kingdom, W1G 8SE
    • St. Bartholomew's Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Sheffield, United Kingdom
    • Northern General Hospital
  • Southampton, United Kingdom
    • Southampton General
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
      • Papworth Hospital
  • Yorkshire
    • Leeds, Yorkshire, United Kingdom, LS1 1YY
      • Leeds General Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 (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

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: S-ICD Pulse Generator; S-ICD Subcutaneous Electrode; S-ICD Electrode Insertion Tool; S-ICD Programmer
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; 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.; Other Names: S-ICD Pulse Generator; S-ICD Subcutaneous Electrode; S-ICD Electrode Insertion Tool; S-ICD Programmer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension Phase Rate of Long-term S-ICD System-related Adverse Events	Rate of adverse events related to the S-ICD system in subjects of the EFFORTLESS Extension Phase sub study	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	Number of S-ICD replacements with another type of implantable defibrillator for functionality unavailable with an S-ICD, such as a need for additional brady therapy, cardiac resynchronization therapy, antitachycardia pacing, or other similar reasons	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	Minimum Implant Time (Days). The data includes information on devices tracked from the date of implant until they went out of service, as well as devices tracked from implant until the last available follow-up before the subject exited the study for any reason (such as study conclusion, death, or withdrawal). Devices still functioning at the end of their observation period continue to add to their longevity beyond this period. Thus, the reported value underestimates actual device longevity, representing only the minimum duration these devices were known to function.	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 Rate of Complications Related to the S-ICD Replacements	K-M Estimate (%) for freedom of complications related to the S-ICD replacements	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 Appropriate Shock Therapy for VT/VF	K-M Estimate (%) for Freedom of appropriate shock therapy for VT/VF	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 Inappropriate Shock Therapy	K-M Estimate (%) for Freedom of Inappropriate Shock Therapy	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 VF Induction Testing at Replacement	Percentage of VF induction testing at replacement	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 Additional Invasive Interventions	Number of Additional invasive interventions	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 Additional Invasive Interventions	Number of subjects with additional invasive interventions	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 Use of Anti-arrhythmic Drugs	Number of subjects in the Extension Phase using anti-arrhythmic drugs	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 Ventricular Rate of Episodes (Mean)	Ventricular rate in of episodes in beats per minute	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 Ventricular Rate of Episodes (Median)	Ventricular rate in of episodes in beats per minute	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 Ventricular Rate of Episodes (IQR)	Ventricular rate in of episodes in beats per minute	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 Ventricular Rate of Non-Sustained Episodes (Mean)	Ventricular rate in of episodes in beats per minute	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 Ventricular Rate of Non-Sustained Episodes (Median)	Ventricular rate in of episodes in beats per minute	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 Ventricular Rate of Non-Sustained Episodes (IQR)	Ventricular rate in of episodes in beats per minute	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.
Complication Events	Summary of all reported complications defined as a clinical event that results in invasive intervention.	From enrollment in the initial main study until the 5th annual follow-up of the substudy.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Pier Lambiase, Prof., St. Bartholomew's Hospital, London

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2011
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimated): March 11, 2010

Study Record Updates

• Last Update Posted (Actual): May 20, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ICD; defibrillator
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 90904925; 90904928

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes