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
  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: AVNS ON

Study Type: Interventional
Study Design: 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:


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.


Enrollment: 45
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT01095952     History of Changes
Other Study ID Numbers: AVNS
Study First Received: March 11, 2010
Last Updated: February 14, 2014
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 August 28, 2014