AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF

NCT01095952 | Completed

• 1 other identifier: AVNS
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 4

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; inappropriate shock; AV-node stimulation; ventricular arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To evaluate the performance of the investigational algorithm in shock reduction.

  baseline, 1 month, 3 months, 6 months

• To evaluate the safety of the investigational algorithm.

  baseline, 1 month, 3 months, 6 months

• To gather data for further possible applications.

  baseline, 1 month, 3 months, 6 months

• To collect data on selective placement of the atrial lead.

  baseline, 1 month, 3 months, 6 months

Study Arms (1)

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.

Device: AVNS ON

Interventions

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.

Also known as: AVNS, AV-node stimulation, parasympathetic AV-node stimulation

AVNS ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (4)

Klinikum Aachen

Aachen, 52074, Germany

Location

Institute of Internal Medicine and Cardiology, Firenze

Florence, 50134, Italy

Location

Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome

Rome, I- 00186, Italy

Location

Department of Cardiology, University Hospital

Uppsala, SE-751 85, Sweden

Location

Related Publications (4)

• 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.

  PMID: 19716083 BACKGROUND

• 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.

  PMID: 18758932 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.

  PMID: 18631264 BACKGROUND

• 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.

  PMID: 25878323 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephano Bianchi, MD

  Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 30, 2010
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

SE (1); DE (1); IT (2)