An interventional study of AVNS ON in Atrial Fibrillation, sponsored by Medtronic BRC. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-17.
Sponsored by Medtronic BRC · Not applicable, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 45 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Medtronic BRC is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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;
Time frame: baseline, 1 month, 3 months, 6 months
To evaluate the safety of the investigational algorithm.
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.
Time frame: baseline, 1 month, 3 months, 6 months
To gather data for further possible applications.
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).
Time frame: baseline, 1 month, 3 months, 6 months
To collect data on selective placement of the atrial lead.
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.
Time frame: baseline, 1 month, 3 months, 6 months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Medtronic BRC