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Trial record 1 of 1 for:    LSR of Acuity - Longitudinal Surveillance Registry of the Acuity™ Spiral Lead
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00955708
Recruitment Status : Active, not recruiting
First Posted : August 10, 2009
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Condition or disease Intervention/treatment
Heart Failure Device: ACUITY Spiral Left Ventricular Lead

Study Type : Observational
Actual Enrollment : 1308 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
Actual Study Start Date : August 4, 2009
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : July 2018

Group/Cohort Intervention/treatment
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead



Primary Outcome Measures :
  1. Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be a broad base representative of those recieving the ACUITY Spiral lead.
Criteria

Inclusion Criteria:

  • Has been or will be implanted with the ACUITY Spiral Lead within 29 days
  • Plans to remain in the long-term care of his/her enrolling physician
  • Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
  • Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Exclusion Criteria:

  • Is unable or unwilling to comply with the protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955708


  Show 97 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Olaf Hedrich, MD Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00955708     History of Changes
Other Study ID Numbers: LSR of ACUITY Spiral
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases