AV-node Stimulation Download Study - Full Text View

Sponsor:	Medtronic BRC
Information provided by:	Medtronic BRC
ClinicalTrials.gov Identifier:	NCT01095952

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Device: Consulta downloaded with AVNS (AV-node stimulation) algorithm to provide high frequency bursting.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Shock

U.S. FDA Resources

Further study details as provided by Medtronic BRC:

Primary Outcome Measures:

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. [ Time Frame: baseline and 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the performance of the investigational algorithm in shock reduction. [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
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;
To evaluate the safety of the investigational algorithm. [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
To evaluate the safety of the investigational algorithm, assessing:
- The rate of adverse device effects and serious adverse device effects related to the investigational algorithm;
- The number of VT/VF or AT/AF episodes potentially induced or prolonged by the investigational algorithm.
To gather data for further possible applications. [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
To gather data for further possible applications of AVNS, assessing:
- the performance of the investigational algorithm in decreasing mean VR and standard deviation directly after 30 seconds of AVNS as compared to 30 seconds directly before algorithm intervention (baseline: all patients; 1, 3 and 6 months follow-up: patients in AF only);
- the performance of the investigational algorithm in combination with ventricular pacing in decreasing mean VR and standard deviation directly after 30 seconds of AVNS as compared to 30 seconds directly before algorithm intervention (baseline only).
To collect data on selective placement of the atrial lead. [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
evaluating:
- electrical characteristics (impedance, threshold, sensing, FFRW) related to pacing and AVNS at implant (when applicable), baseline and follow-ups;
- the percentage of atrial lead implantations with electrical characteristics suitable both for standard pacing and AVNS;
- adverse events related to selective atrial lead placement at implant and in the follow-up;
- mean duration of implant procedure and mean fluoroscopic time;
- the presence of an implant learning curve.

Estimated Enrollment:	55
Study Start Date:	November 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AVNS on AVNS will be programmed on for five months. The feasibility and safety of the AVNS algorithm to reduce inappropriate shocks will be monitored.	Device: Consulta downloaded with AVNS (AV-node stimulation) algorithm to provide high frequency bursting. 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. Other Names: AVNS AV-node stimulation parasympathetic AV-node stimulation

Arms

Assigned Interventions

Experimental: AVNS on

AVNS will be programmed on for five months. The feasibility and safety of the AVNS algorithm to reduce inappropriate shocks will be monitored.

Device: Consulta downloaded with AVNS (AV-node stimulation) algorithm to provide high frequency bursting.

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.

Other Names:

AVNS
AV-node stimulation
parasympathetic AV-node stimulation

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095952

Locations

Germany
Klinikum Aachen
Aachen, Germany, 52074
Italy
Institute of Internal Medicine and Cardiology, Firenze
Firenze, Italy, 50134
Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
Rome, Italy, I- 00186
Sweden
Department of Cardiology, University Hospital
Uppsala, Sweden, SE-751 85

Sponsors and Collaborators

Medtronic BRC

Investigators

Principal Investigator:

Stephano Bianchi, MD

Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli

More Information

Publications:

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. Epub 2009 May 9.

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. Epub 2008 Aug 30.

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. Epub 2008 Jul 3.

Responsible Party:	Lilian Kornet, Senior Scientist, Bakken Research Center, Medtronic
ClinicalTrials.gov Identifier:	NCT01095952 History of Changes
Other Study ID Numbers:	AVNS
Study First Received:	March 11, 2010
Last Updated:	June 30, 2011
Health Authority:	Germany: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Sweden: Medical Products Agency

Keywords provided by Medtronic BRC:

atrial fibrillation
inappropriate shock
AV-node stimulation
ventricular arrhythmia

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012