Cameron Health Post Market S-ICD Registry (EFFORTLESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Cameron Health, Inc.
Sponsor:
Information provided by (Responsible Party):
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01085435
First received: March 10, 2010
Last updated: February 4, 2013
Last verified: February 2013

March 10, 2010
February 4, 2013
October 2010
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01085435 on ClinicalTrials.gov Archive Site
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Cameron Health 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 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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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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 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2017
January 2014   (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. 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
Both
18 Years and older
No
Contact: Helen Reeve-Stoffer, PhD +44 794 774 8006 helen.reevestoffer@bsci.com
Contact: Michael Husby +1 312 402 1877 michael.husby@bsci.com
Czech Republic,   Denmark,   Germany,   Netherlands,   New Zealand,   United Kingdom
 
NCT01085435
DN-15627; DN 15677
Yes
Cameron Health, Inc.
Cameron Health, Inc.
Not Provided
Study Chair: Pier Lambiase, PhD FRCP The Heart Hospital, London
Cameron Health, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP