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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVNS ON | Experimental | Consulta downloaded with AVNS to provide high frequency bursting during fastly conducted AF. AVNS will be programmed on for five months. The feasibility and safety of the AVNS algorithm to reduce inappropriate shocks will be monitored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVNS ON | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the performance of the investigational algorithm in reducing mean VR during AF, the relative reduction of VR during AVNS will be assessed in acute in-hospital tests, conducted preferably during either spontaneous or induced episodes of AF. | baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the performance of the investigational algorithm in shock reduction. | assessing the number of successful rate reduction interventions by AVNS during spontaneous episodes of AF occurring during follow-up, with rapid VR due to AF conducted in the VT/FVT/VF zone; | baseline, 1 month, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephano Bianchi, MD | Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Aachen | Aachen | 52074 | Germany | |||
| Institute of Internal Medicine and Cardiology, Firenze |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19716083 | Background | Bianchi S, Rossi P, Della Scala A, Kornet L, Pulvirenti R, Monari G, Di Renzi P, Schauerte P, Azzolini P. Atrioventricular (AV) node vagal stimulation by transvenous permanent lead implantation to modulate AV node function: safety and feasibility in humans. Heart Rhythm. 2009 Sep;6(9):1282-6. doi: 10.1016/j.hrthm.2009.05.011. Epub 2009 May 9. | |
| 18758932 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2016 | |
| Reset | Aug 8, 2016 | |
| Release | Oct 21, 2019 | |
| Reset | Nov 7, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2016 | Aug 8, 2016 | |||
| Oct 21, 2019 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| To evaluate the safety of the investigational algorithm. |
To evaluate the safety of the investigational algorithm, assessing:
|
| baseline, 1 month, 3 months, 6 months |
| To gather data for further possible applications. | To gather data for further possible applications of AVNS, assessing:
| baseline, 1 month, 3 months, 6 months |
| To collect data on selective placement of the atrial lead. | evaluating:
| baseline, 1 month, 3 months, 6 months |
| Florence |
| 50134 |
| Italy |
| Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome | Rome | I- 00186 | Italy |
| Department of Cardiology, University Hospital | Uppsala | SE-751 85 | Sweden |
| Rossi P, Bianchi S, Barretta A, Della Scala A, Kornet L, De Paulis R, Bellisario A, D'Addio V, Pavaci H, Miraldi F. Post-operative atrial fibrillation management by selective epicardial vagal fat pad stimulation. J Interv Card Electrophysiol. 2009 Jan;24(1):37-45. doi: 10.1007/s10840-008-9286-2. Epub 2008 Aug 30. |
| 18631264 | Background | Bianchi S, Rossi P, Della Scala A, Kornet L. Endocardial transcatheter stimulation of the AV nodal fat pad: stabilization of rapid ventricular rate response during atrial fibrillation in left ventricular failure. J Cardiovasc Electrophysiol. 2009 Jan;20(1):103-5. doi: 10.1111/j.1540-8167.2008.01243.x. Epub 2008 Jul 3. |
| 25878323 | Derived | Bianchi S, Rossi P, Schauerte P, Elvan A, Blomstrom-Lundqvist C, Kornet L, Gal P, Mortsell D, Wouters G, Gemein C. Increase of ventricular interval during atrial fibrillation by atrioventricular node vagal stimulation: chronic clinical atrioventricular-nodal stimulation download study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):562-8. doi: 10.1161/CIRCEP.114.002588. Epub 2015 Apr 15. |
| Nov 7, 2019 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |