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

Medtronic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: AVNS ON

Study type: Interventional

Funder types: Industry

Identifiers

NCT01095952

AVNS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

AVNS ON

Experimental group

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.

Treatment:

Device: AVNS ON