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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
  Purpose

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.

  Eligibility

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

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. 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 ClinicalTrials.gov identifier: NCT01085435

Contacts
Contact: Valérie Lens +32 491 15 39 90 lensv@bsci.com
Contact: Michael Husby +1 312 402 1877 michael.husby@bsci.com

Locations
Czech Republic
Na Homolce Hospital Recruiting
Prague, Prague 5, Czech Republic, 15030
Contact: Dr Petr Neuzil, MD PhD         
Denmark
Rigshospitalet Recruiting
Copenhagen, København Ø, Denmark, 2100
Contact: Dr Regitze Videbaek, MD PhD         
Odense University Hospital Recruiting
Odense, Odense C, Denmark, DK-5000
Contact: Dr Jens B Johansen, MD PhD         
Germany
Herzzentrum Bernau Recruiting
Bernau, Germany
Contact: Dr C Butter, MD         
Klinikum Coburg Active, not recruiting
Coburg, Germany, 96450 Coburg
Munich Groβhadern Recruiting
Munich, Germany, 81377
Contact: Prof S Kääb, MD         
Netherlands
Maastricht University Medical Center Active, not recruiting
Maastricht, AZ Maastricht, Netherlands, 6202
Catharina Eindhoven Hospital Recruiting
Eindhoven, EJ Eindhoven, Netherlands, 5623
Contact: Dr Lucas Dekker, MD         
Amsterdam Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Dr R Knops, MD         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7513 ER
Contact: Dr Marcoen Scholten, MD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713
Contact: Dr Alexander Maas, MD         
St Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3430 EM
Contact: Dr Lucas Boersma, MD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Dr Dominic Theuns, PhD         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Dr Margaret Hood, MD         
Principal Investigator: Margaret Hood, MD         
Sub-Investigator: Warren Smith, MD         
United Kingdom
Papworth Hospital Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Dr Sharad Agarwal, MD MRCP         
Principal Investigator: Dr Sharad Agarwal, MD MRCP         
Sub-Investigator: Dr Andrew Grace, MD PhD         
Leeds General Infirmary Recruiting
Leeds, Yorkshire, United Kingdom, LS1 1YY
Contact: Dr Chris Pepper, MD         
Royal Sussex County Hospital Active, not recruiting
Brighton, United Kingdom, BN2 5BE
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Dr Graham Stuart, MB ChB, FRCP         
Russells Hall Hospital Recruiting
Dudley, United Kingdom, DY1 2HQ
Contact: Dr Craig Barr, MRCP         
Yorkhill Children's Hospital Recruiting
Glasgow, United Kingdom, G3 8SJ
Contact: Dr Karen McLeod, MD         
The Heart Hospital Recruiting
London, United Kingdom, W1G 8SE
Contact: Dr Pier Lambiase, PhD FRCP         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Dr R Khiani, MD         
Contact: Dr M Jones, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01085435     History of Changes
Other Study ID Numbers: DN-15627; DN 15677
Study First Received: March 10, 2010
Last Updated: September 23, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:
ICD
defibrillator

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

ClinicalTrials.gov processed this record on November 27, 2014