Trials / Completed
CompletedNCT00811551
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices
zWedge Clinical Feasibility IDE Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 22 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.
Detailed description
Intra-thoracic impedance will be obtained at programmed intervals by using an investigational monitoring feature in the CRT-D device. To obtain impedance values, the device delivers a sub-threshold impulse that measures the resistance between 2 electrodes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRT-D (Intra-thoracic Impedance Monitoring) | Diagnostic Feature in CRT-D device that emits a sub-threshold pulse to measure resistance between two electrodes. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2008-12-19
- Last updated
- 2019-02-04
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00811551. Inclusion in this directory is not an endorsement.