Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

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: NCT00869921
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

Tracking Information
First Submitted Date March 25, 2009
First Posted Date March 26, 2009
Last Update Posted Date September 13, 2018
Study Start Date March 2009
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2011)
Lead-related complication rate. [ Time Frame: Implant to 5 years post-implant. ]
Original Primary Outcome Measures
 (submitted: March 25, 2009)
Evaluate lead-related complication rate [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: May 22, 2014)
Types of Model 4195 lead-related events [ Time Frame: 5 years post implant ]
Original Secondary Outcome Measures
 (submitted: March 25, 2009)
Model 4195 lead-related events [ Time Frame: 5 years post implant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
Official Title Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Brief Summary 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 Medtronic's post-market surveillance platform.
Detailed Description Model 4195 LV lead complication-free survivability will be summarized.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2015)
1322
Original Estimated Enrollment
 (submitted: March 25, 2009)
1778
Actual Study Completion Date April 3, 2018
Actual Primary Completion Date April 3, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United Kingdom,   United States
Removed Location Countries Austria,   Belgium,   France,   Germany,   Italy,   Netherlands
 
Administrative Information
NCT Number NCT00869921
Other Study ID Numbers 4195 Chronic Performance
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic
Study Sponsor Medtronic
Collaborators Not Provided
Investigators
Study Chair: 4195 LV Lead Chronic Performance Study Team Medtronic
PRS Account Medtronic
Verification Date September 2018