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Boston Scientific Post Market S-ICD Registry (EFFORTLESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01085435
First received: March 10, 2010
Last updated: September 23, 2014
Last verified: September 2014

March 10, 2010
September 23, 2014
October 2010
December 2020   (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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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 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
Not Provided
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
Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kääb S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2020
December 2020   (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: Valérie Lens +32 491 15 39 90 lensv@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
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Chair: Pier Lambiase, PhD FRCP The Heart Hospital, London
Boston Scientific Corporation
September 2014

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