Clinical trial NCT01095952: AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF
Official title: Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
inappropriate shock
AV-node stimulation
ventricular arrhythmia
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with a documented history of paroxysmal or persistent AF are eligible to be enrolled in the study if one of the following criteria is met:
* Indication for CRT implant according to current Guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction ≤35% and QRS≥120ms); OR
* Indication for upgrading to CRT-D from a single chamber device; OR
* Indication for upgrading to CRT-D from a dual chamber device with septal atrial lead or a dislodged atrial lead; OR
* Indication for device replacement or surgical revision in patients already implanted with a CRT-D device and an atrial lead in the septal position or a dislodged atrial lead; OR
* Patients already implanted with a ConsultaTM device and an atrial lead in the septal position, requiring electrical cardioversion.

Exclusion Criteria:

* If any of the following criteria are met, patient cannot be enrolled in the study:
* Permanent atrial fibrillation;
* Patients who are not on anti-coagulant therapy;
* Advanced AV block (II-III degree AV block);
* Patients previously submitted to valvular surgery;
* Patients previously submitted to AV or AF ablative procedures;
* Age \< 18 years;
* Patient not disposed to sign the Informed Consent;
* Participation in other studies which could potentially conflict with this study;

Primary outcomes:
measure: 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.
timeFrame: baseline and 1 month
Secondary outcomes:
measure: To evaluate the performance of the investigational algorithm in shock reduction.
timeFrame: baseline, 1 month, 3 months, 6 months
measure: To evaluate the safety of the investigational algorithm.
timeFrame: baseline, 1 month, 3 months, 6 months
measure: To gather data for further possible applications.
timeFrame: baseline, 1 month, 3 months, 6 months
measure: To collect data on selective placement of the atrial lead.
timeFrame: baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Klinikum Aachen
city: Firenze
country: Italy
facility: Institute of Internal Medicine and Cardiology, Firenze
city: Rome
country: Italy
facility: Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
city: Uppsala
country: Sweden
facility: Department of Cardiology, University Hospital
Study officials:
affiliation: Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli
name: Stephano Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.