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REASSURE AV Registry (REASSURE Reg)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01074034
First received: February 22, 2010
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.


Condition Intervention
Sudden Cardiac Death
Bradycardia
 Device: B301 ASSURE Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Research Evaluation of the ASSURE Device Atrial and Ventricular Tachyarrhythmia Therapies Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Incidences of ventricular shock therapy [ Time Frame: Report annually ] [ Designated as safety issue: Yes ]
    There are no statistical endpoints for this registry. Incidences of ventricular shock therapy and their suspected causes and outcome will be the primary focus of this registry.


Enrollment: 157
Study Start Date: April 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B301 Device Device: B301 ASSURE Device
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol
  • Patient is implanted with an investigational B301 device as part of the REASSURE AV study

Exclusion Criteria:

* None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074034

  Show 36 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01074034     History of Changes
Other Study ID Numbers: G040067
Study First Received: February 22, 2010
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tachycardia, Ventricular
Death, Sudden, Cardiac
Death
Bradycardia
Tachycardia
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on May 21, 2013