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AzTrials

Atrial FibrillationAVNSNCT01095952

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

A study testing AVNS ON in people with Atrial Fibrillation, run by Medtronic BRC at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
AVNS ON
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
4 sitesin 3 countries
Study dates
Nov 2011to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • Age < 18 years;
  • Patient not disposed to sign the Informed Consent;
  • Participation in other studies which could potentially conflict with this study;

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Italy2 sites

  • Institute of Internal Medicine and Cardiology, Firenze

    Florence, 50134

  • Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome

    Rome, I- 00186

Other trials in Italy

Germany1 site

  • Klinikum Aachen

    Aachen, 52074

Other trials in Germany

Sweden1 site

  • Department of Cardiology, University Hospital

    Uppsala, SE-751 85

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
AVNS ON
Keywords
atrial fibrillation, inappropriate shock, AV-node stimulation, ventricular arrhythmia
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVNS ONDevice

    Also called AVNS, AV-node stimulation, parasympathetic AV-node stimulation

    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.

Study groups in NCT01095952
Study groupRoleWhat they receive
AVNS ONExperimentalConsulta 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.
Receives: Device: AVNS ON

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 1 month

Secondary outcomes (4)

  1. 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;

    Measured: baseline, 1 month, 3 months, 6 months

  2. 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.

    Measured: baseline, 1 month, 3 months, 6 months

  3. 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).

    Measured: baseline, 1 month, 3 months, 6 months

  4. 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.

    Measured: baseline, 1 month, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2010 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01095952
Sponsor's protocol ID
AVNS
Acronym
AVNS
Status last verified
Feb 2014
First submitted
11 Mar 2010
Last updated
17 Feb 2014
Results posted
No
Data monitoring committee
No

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. doi: 10.1016/j.hrthm.2009.05.011. Epub 2009 May 9.

    PubMed 19716083

  • 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. doi: 10.1007/s10840-008-9286-2. Epub 2008 Aug 30.

    PubMed 18758932

  • 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. doi: 10.1111/j.1540-8167.2008.01243.x. Epub 2008 Jul 3.

    PubMed 18631264

  • Bianchi S, Rossi P, Schauerte P, Elvan A, Blomstrom-Lundqvist C, Kornet L, Gal P, Mortsell D, Wouters G, Gemein C. Increase of ventricular interval during atrial fibrillation by atrioventricular node vagal stimulation: chronic clinical atrioventricular-nodal stimulation download study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):562-8. doi: 10.1161/CIRCEP.114.002588. Epub 2015 Apr 15.

    PubMed 25878323

Questions about this trial

What is this clinical trial studying?

A study testing AVNS ON in people with Atrial Fibrillation, run by Medtronic BRC at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01095952, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.

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