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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT01095952
First received: March 11, 2010
Last updated: February 14, 2014
Last verified: February 2014

March 11, 2010
February 14, 2014
November 2011
November 2013   (final data collection date for primary outcome 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. [ Time Frame: baseline and 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01095952 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF
Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
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.
Other Names:
  • AVNS
  • AV-node stimulation
  • parasympathetic AV-node stimulation
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.
Intervention: Device: AVNS ON

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
November 2013
November 2013   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Sweden
 
NCT01095952
AVNS
No
Medtronic BRC
Medtronic BRC
Not Provided
Principal Investigator: Stephano Bianchi, MD Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli
Medtronic BRC
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP