Cameron Health Post Market S-ICD Registry (EFFORTLESS)
This study is currently recruiting participants.
Verified February 2013 by Cameron Health, Inc.
Sponsor:
Cameron Health, Inc.
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
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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 Cameron Health, Inc.:
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 2017 |
| Estimated Primary Completion Date: | January 2014 (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:
|
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
- Age >/= 18yrs
- 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)
- 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
- Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085435
Contacts
| Contact: Helen Reeve-Stoffer, PhD | +44 794 774 8006 | helen.reevestoffer@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 | Not yet recruiting |
| Coburg, Germany, 96450 Coburg | |
| Contact: Prof. Johannes Brachmann, MD | |
| 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
Cameron Health, Inc.
Investigators
| Study Chair: | Pier Lambiase, PhD FRCP | The Heart Hospital, London |
More Information
No publications provided
| Responsible Party: | Cameron Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT01085435 History of Changes |
| Other Study ID Numbers: | DN-15627; DN 15677 |
| Study First Received: | March 10, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Cameron Health, Inc.:
|
ICD defibrillator |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013