Boston Scientific Post Market S-ICD Registry (EFFORTLESS)

March 4, 2024 updated by: Boston Scientific Corporation

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitätsklinikum Münster
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 30 days post implant
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
Time Frame: Minimum 360 days post implant
The Kaplan-Meier (KM) Survival Estimate of 360-Day Type I Complications.
Minimum 360 days post implant
Percentage of Inappropriate Shocks for AF/SVT
Time Frame: From enrollment to 5-year annual visit.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Chair: Pier Lambiase, Prof., St. Bartholomew's Hospital, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tachycardia, Ventricular

Clinical Trials on S-ICD System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe