AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF (AVNS)
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|ClinicalTrials.gov Identifier: NCT01095952|
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : February 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: AVNS ON||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: AVNS ON
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.
- 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. [ Time Frame: baseline, 1 month, 3 months, 6 months ]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 ]
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 ]
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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095952
|Aachen, Germany, 52074|
|Institute of Internal Medicine and Cardiology, Firenze|
|Firenze, Italy, 50134|
|Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome|
|Rome, Italy, I- 00186|
|Department of Cardiology, University Hospital|
|Uppsala, Sweden, SE-751 85|
|Principal Investigator:||Stephano Bianchi, MD||Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli|