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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AVNS ON
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, inappropriate shock, AV-node stimulation, ventricular arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Klinikum Aachen
  • Institute of Internal Medicine and Cardiology, Firenze
  • Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
  • Department of Cardiology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVNS ON

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

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;
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.
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).
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.

Full Information

First Posted
March 11, 2010
Last Updated
February 14, 2014
Sponsor
Medtronic BRC
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1. Study Identification

Unique Protocol Identification Number
NCT01095952
Brief Title
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF
Acronym
AVNS
Official Title
Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, inappropriate shock, AV-node stimulation, ventricular arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVNS ON
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
AVNS ON
Other Intervention Name(s)
AVNS, AV-node stimulation, parasympathetic AV-node stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the performance of the investigational algorithm in shock reduction.
Description
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
Title
To evaluate the safety of the investigational algorithm.
Description
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
Title
To gather data for further possible applications.
Description
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
Title
To collect data on selective placement of the atrial lead.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephano Bianchi, MD
Organizational Affiliation
Department of Cardiology, Hospital Rome, ospedalis giovanni calibita fatebenefratelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Institute of Internal Medicine and Cardiology, Firenze
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome
City
Rome
ZIP/Postal Code
I- 00186
Country
Italy
Facility Name
Department of Cardiology, University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19716083
Citation
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.
Results Reference
background
PubMed Identifier
18758932
Citation
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.
Results Reference
background
PubMed Identifier
18631264
Citation
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.
Results Reference
background
PubMed Identifier
25878323
Citation
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.
Results Reference
derived

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

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