Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic
Information provided by (Responsible Party):
Medtronic
ClinicalTrials.gov Identifier:
NCT00930904
First received: June 30, 2009
Last updated: April 6, 2016
Last verified: April 2016
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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 and is integrated within the Product Surveillance Registry (PAN Registry).
| Condition |
|---|
|
Heart Failure |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study |
Further study details as provided by Medtronic:
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: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
Model 4196 LV lead complication-free survivability will be summarized.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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 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 Ability Model 4196 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: NCT00930904
Show 103 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930904
Show 103 Study Locations
Sponsors and Collaborators
Medtronic
Investigators
| Study Chair: | 4196 LV Lead Chronic Performance Study Team | Medtronic |
More Information
| Responsible Party: | Medtronic |
| ClinicalTrials.gov Identifier: | NCT00930904 History of Changes |
| Other Study ID Numbers: | 4196 Chronic Performance |
| Study First Received: | June 30, 2009 |
| Last Updated: | April 6, 2016 |
| 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 September 26, 2016