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
  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:


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
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: 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 July 24, 2014