Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants.
Verified March 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00869921
First received: March 25, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Lead-related complication rate. [ Time Frame: Implant to 5 years post-implant. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Types of Model 4195 lead-related adverse events [ Time Frame: 5 years post implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 1778
Study Start Date: March 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Model 4195 LV lead complication-free survivability will be summarized.

  Eligibility

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

Patients implanted with a 4195 LV Lead within the last 6 months. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject or appropriate legal guardian provides written informed consent and authorization for access to and use of health information (if applicable)
  • Complete implant and follow-up data, including Model 4195 lead-related events are available

AND one of the following must apply:

  • Subject is within six months post-implant of a 4195 Model lead connected to a market released Cardiac Resynchronization Therapy (Cardiac Resynchronization Therapy-Pacemaker or Cardiac Resynchronization Therapy-Defibrillator) device. The Medtronic lead must be used for a pacing or sensing application.
  • Subject who participated in the Medtronic Attain StarFix Model 4195 Left Ventricular Lead Pre-Market Study.

Exclusion Criteria:

  • Subject implanted at a non-participating site, and implant, follow-up data, including Model 4195 lead-related events are not available within 30 days from implant
  • Subject who is, or will be inaccessible for follow-up at a study site
  • Subject with exclusion criteria required by local law (Europe, Middle East or Africa only)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869921

Contacts
Contact: 4195 LV Lead Chronic Performance Team medtroniccrmtrials@medtronic.com

  Show 124 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: 4195 LV Lead Chronic Performance Study Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00869921     History of Changes
Other Study ID Numbers: 4195 Chronic Performance
Study First Received: March 25, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Ethics Review Committee
France: Conseil National de l'Ordre des Médecins
Austria: Ethikkommission
Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014