Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00930904
First received: June 30, 2009
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead. This study is part of the Product Performance Platform (PPP).
| Condition |
|---|
|
Heart Failure |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Attain Ability® Model 4196 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: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Types of lead-related events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
- Percent of fractures with loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Mean bipolar pacing threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1778 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
Lead 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 4196 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 4196 lead-related events are available.
AND one of the following must apply:
- Subject is within six months post-implant of a 4196 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 Ability Model 4196 Left Ventricular Lead Pre-Market Study.
Exclusion Criteria:
- Subject implanted at a non-participating site, and implant, follow-up data, including Model 4196 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: NCT00930904
Show 120 Study Locations
Show 120 Study LocationsSponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
| Study Chair: | 4196 LV Lead Chronic Performance Study Team | Medtronic |
More Information
No publications provided
| Responsible Party: | Medtronic Cardiac Rhythm Disease Management |
| ClinicalTrials.gov Identifier: | NCT00930904 History of Changes |
| Other Study ID Numbers: | 4196 Chronic Performance |
| Study First Received: | June 30, 2009 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Canada: Ethics Review Committee Italy: Ethics Committee Denmark: Ethics Committee France: Conseil National de l'Ordre des Médecins Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013