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

Atrial Fibrillation Clinical Trial

— AVNS  

Official title:

Reduction of Ventricular Rate During Atrial Fibrillation by AV Node Stimulation" AVNS Download Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095952
• Other study ID #: AVNS
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: February 14, 2014
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum Aachen	Aachen
Italy	Institute of Internal Medicine and Cardiology, Firenze	Firenze
Italy	Department of Cardiology, Ospedalis Giovanni Calibita Fatebenefratelli, Rome	Rome
Sweden	Department of Cardiology, University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Germany,  Italy,  Sweden, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline and 1 month
Secondary	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;	baseline, 1 month, 3 months, 6 months
Secondary	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.	baseline, 1 month, 3 months, 6 months
Secondary	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).	baseline, 1 month, 3 months, 6 months
Secondary	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.	baseline, 1 month, 3 months, 6 months