Boston Scientific Post Market S-ICD Registry (EFFORTLESS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: March 10, 2010
Last updated: December 1, 2014
Last verified: September 2014
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Cameron Health 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 DN 15627 (Aug 06, 2010) restricts enrolment to patients over 18 years of age while protocol amendment DN 15677 (Aug 30, 2010) allows all patients to be included. Countries can chose their route for approval

Condition Intervention
Tachycardia, Ventricular
Device: S-ICD System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Perioperative S-ICD Complication Free Rate [ Time Frame: 30 days post implant ] [ Designated as safety issue: No ]
  • 360 Day S-ICD Complication Free Rate [ Time Frame: Minimum 360 days post implant ] [ Designated as safety issue: No ]
  • Percentage of inappropriate shocks for AF/SVT [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
S-ICD System Commercial Patients
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 SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).
Other Names:
  • SQ-RX Pulse Generator
  • Q-TRAK Subcutaneous Electrode
  • Q-GUIDE Electrode Insertion Tools
  • Q-TECH Programmer

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post CE mark ICD patients eligible for implantation of the S-ICD system

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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01085435

Czech Republic
Na Homolce Hospital
Prague, Prague 5, Czech Republic, 15030
Copenhagen, København Ø, Denmark, 2100
Odense University Hospital
Odense, Odense C, Denmark, DK-5000
Herzzentrum Bernau
Bernau, Germany
Klinikum Coburg
Coburg, Germany, 96450 Coburg
Munich Groβhadern
Munich, Germany, 81377
Maastricht University Medical Center
Maastricht, AZ Maastricht, Netherlands, 6202
Catharina Eindhoven Hospital
Eindhoven, EJ Eindhoven, Netherlands, 5623
Amsterdam Medical Center
Amsterdam, Netherlands, 1105 AZ
Medisch Spectrum Twente
Enschede, Netherlands, 7513 ER
University Medical Center Groningen
Groningen, Netherlands, 9713
St Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1142
United Kingdom
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom, LS1 1YY
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
Yorkhill Children's Hospital
Glasgow, United Kingdom, G3 8SJ
The Heart Hospital
London, United Kingdom, W1G 8SE
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Boston Scientific Corporation
Study Chair: Pier Lambiase, PhD FRCP The Heart Hospital, London
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation Identifier: NCT01085435     History of Changes
Other Study ID Numbers: DN-15627; DN 15677
Study First Received: March 10, 2010
Last Updated: December 1, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on November 27, 2015