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Trial record 1 of 2 for:    EFFORTLESS registry
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Boston Scientific Post Market S-ICD Registry (EFFORTLESS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085435
First Posted: March 11, 2010
Last Update Posted: September 11, 2017
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.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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.

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 ]
  • 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 ]

Estimated Enrollment: 1000
Actual Study Start Date: October 2010
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: November 24, 2019 (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 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

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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post CE mark ICD patients eligible for implantation of the S-ICD system
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085435


  Show 45 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Chair: Pier Lambiase, Prof. St. Bartholomew's Hospital, London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01085435     History of Changes
Other Study ID Numbers: 90904925; 90904928
First Submitted: March 10, 2010
First Posted: March 11, 2010
Last Update Posted: September 11, 2017
Last Verified: August 2017

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

Keywords provided by Boston Scientific Corporation:
ICD
defibrillator

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes