Trials / Completed
CompletedNCT02367716
Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).
Detailed description
This is a multi-center, non-randomized observational study. The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRT | The study will include the Quartet™ family of left heart leads or any newer St. Jude Medical quadripolar CRT systems, including CRT-P systems, that China Food and Drug Administration (CFDA) might approve in the future |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-10-01
- Completion
- 2017-03-01
- First posted
- 2015-02-20
- Last updated
- 2020-11-18
- Results posted
- 2020-11-18
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02367716. Inclusion in this directory is not an endorsement.