S-ICD® System Post Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Cameron Health, Inc.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT01736618
First received: November 27, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.


Condition Intervention
Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest
Device: S-ICD System

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: S-ICD® System Post Approval Study

Resource links provided by NLM:


Further study details as provided by Cameron Health, Inc.:

Primary Outcome Measures:
  • Type I Complication Free Rate [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
    Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.

  • Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
    Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances.


Secondary Outcome Measures:
  • Electrode-Related Complication Free Rate. [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
    A complication is an adverse event that results in permanent loss of device function, invasive intervention or death.

  • First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Freedom from complications requiring surgical revisions of the pulse generator or electrode, including pocket revisions, surgical repositioning or removal of the device in response to product performance issues [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Individual rates of each adverse event category contributing to the primary and secondary safety endpoints [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
    Will be examined including two-sided 95% exact confidence intervals

  • All cause mortality [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Electrical performance data recorded by the device [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  • Mechanical electrode failures [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Explants and causes [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  • Transvenous ICD (TV-ICD) implantation following subcutaneous ICD (S-ICD) explant [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  • Surgical revisions in response to suboptimal placement or system movement [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Chronic pain/discomfort requiring surgical intervention [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Removal of S-ICD System in response to implant testing [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Syncope associated with VT/VF episodes [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  • Inappropriate shock incidence [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  • Premature battery depletions and other device malfunctions [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1616
Study Start Date: March 2013
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
S-ICD System Implant Attempt Device: S-ICD System

Detailed Description:

The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months.

  • The primary safety endpoint of the study is the Type I (caused by the S-ICD System) Complication Free Rate at 60 months compared to a performance goal of 85%.
  • The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 94%.
  • The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months compared to a performance goal of 92.5%.
  • The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 84.0%.

Additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations.

Subjects must meet the following criteria to be eligible for inclusion in the study:

  1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)
  2. Willing and able to provide written informed consent or have informed consent provided by a legal representative

Subjects who meet the following criteria must be excluded from the study:

1. Remaining life expectancy of less than 360 days

Enrolled subjects will be followed at the implant procedure, predischarge and annual(±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

Criteria

Inclusion Criteria:

  • Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)

AND

  • Willing and able to provide written informed consent or have informed consent provided by a legal representative

Exclusion Criteria:

  • Remaining life expectancy of less than 360 days
  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: NCT01736618

Contacts
Contact: Michael P Husby, MS, MPH 312-402-1877 michael.husby@bsci.com

  Show 33 Study Locations
Sponsors and Collaborators
Cameron Health, Inc.
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Cameron Health, Inc.
ClinicalTrials.gov Identifier: NCT01736618     History of Changes
Other Study ID Numbers: BSC CRM CDM00055718, BSC CRM CDM00055718
Study First Received: November 27, 2012
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cameron Health, Inc.:
subcutaneous implantable defibrillator post approval study sudden cardiac arrest Cameron Health defibrillator

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014