Reduction of Ventricular Rate during Atrial Fibrillation by AV Node Stimulatio

Recruiting

• Conditions: 10007521; Atrial fibrillation; ventricular rate

• Registration Number: NL-OMON37656
• Lead Sponsor: Medtronic Trading NL BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Documented history of paroxysmal or persistent AF
- Indication for CRT implant or upgrade 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 Consulta CRT-D device and an atrial lead in the septal position, requiring electrical cardioversion.

Exclusion Criteria

-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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Protocol page 11<br /><br><br /><br>Primary objective:<br /><br>To evaluate the performance of the investigational AVNS algorithm in reducing<br /><br>mean VR during AF, the relative reduction of VR during AVNS (delivered by the<br /><br>investigational algorithm programmed to maximal output of 8V and 1.5 ms) will<br /><br>be assessed in acute in-hospital tests, conducted preferably during either<br /><br>spontaneous or induced episodes of AF.</p><br>