Boston Scientific Post Market S-ICD Registry (EFFORTLESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085435
Recruitment Status : Enrolling by invitation
First Posted : March 11, 2010
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):
Boston Scientific Corporation

March 10, 2010
March 11, 2010
March 21, 2018
October 2010
November 24, 2019   (Final data collection date for primary outcome measure)
  • Perioperative S-ICD Complication Free Rate [ Time Frame: 30 days post implant ]
  • 360 Day S-ICD Complication Free Rate [ Time Frame: Minimum 360 days post implant ]
  • Percentage of inappropriate shocks for AF/SVT [ Time Frame: Study duration ]
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Complete list of historical versions of study NCT01085435 on Archive Site
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Boston Scientific Post Market S-ICD Registry
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.

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.

A 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.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Post CE mark ICD patients eligible for implantation of the S-ICD system
Tachycardia, Ventricular
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
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.
Intervention: Device: S-ICD System

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
December 2023
November 24, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Czechia,   Denmark,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Portugal,   Spain,   United Kingdom
Czech Republic
90904925; 90904928
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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Boston Scientific Corporation
Boston Scientific Corporation
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Study Chair: Pier Lambiase, Prof. St. Bartholomew's Hospital, London
Boston Scientific Corporation
August 2017