Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 22, 2014
Last verified: May 2014
  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 and is integrated within the Product Surveillance Registry (PAN Registry).


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval 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 events [ Time Frame: 5 years post implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 1778
Study Start Date: March 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (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 past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
  • Patient within 30 day post implant enrollment window

Exclusion Criteria

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
  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: NCT00869921

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

  Show 135 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: May 22, 2014
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 July 31, 2014