Overview

This trial is active, not recruiting.

Condition tachycardia, ventricular
Treatment s-icd system
Sponsor Boston Scientific Corporation
Start date October 2010
End date December 2020
Trial size 1000 participants
Trial identifier NCT01085435, DN-15627; DN 15677

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients implanted with a CE marked S-ICD System, not participating in Cameron Health's Investigational Device Exemption (IDE) Clinical Study.
s-icd system SQ-RX Pulse Generator
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).

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.