Trials / Completed
CompletedNCT02548455
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 499 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
Detailed description
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead. A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide. All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Quartet 1457Q LV Lead |
Timeline
- Start date
- 2015-10-27
- Primary completion
- 2016-08-19
- Completion
- 2017-03-21
- First posted
- 2015-09-14
- Last updated
- 2019-02-04
- Results posted
- 2018-05-08
Locations
30 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02548455. Inclusion in this directory is not an endorsement.