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:
Medtronic Cardiac Rhythm Disease Management
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
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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) |
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
Show 124 Study Locations
Contacts
| Contact: 4195 LV Lead Chronic Performance Team | medtroniccrmtrials@medtronic.com |
Show 124 Study LocationsSponsors 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 May 16, 2013