Trials / Completed
CompletedNCT01095952
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF
Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Medtronic BRC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly conducted atrial fibrillation (AF) by delivering AV node stimulation (AVNS) from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.
Detailed description
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling VR during rapidly conducted AF by delivering AVNS from the atrial lead placed at a septal position, and designed with the purpose of reducing inappropriate shocks. Additional purposes include the assessment of a possible application of AVNS aimed at allowing prolonged control of VR during AF and reducing AF symptoms, and evaluation of implantation data on selective placement of the atrial lead in postero-septal right atrium. About 37 patients will be followed for half a year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AVNS ON | Delaying the AV-node by stimulating the parasympathetic nerves innervating the AV-node with high frequency burst pacing during the refractory period of the ventricle using a standard atrial lead at a septal position. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2010-03-30
- Last updated
- 2014-02-17
Locations
4 sites across 3 countries: Germany, Italy, Sweden
Source: ClinicalTrials.gov record NCT01095952. Inclusion in this directory is not an endorsement.