AF Septal Pacing (Clinical Investigation Plan)

Medtronic

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Procedure: Pulmonary vein ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03242941

AF Septal Pacing

Details and patient eligibility

About

The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.

Full description

The evidence of treating AF by pacing is limited, although these algorithms are of interest, since they appear to be safe and usually add little additional cost.

Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal pacing algorithm could suppress AF reentries in a more robust way than classical single site rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed in the interatrial septum has been previously demonstrated clinically. The septal pacing concept has also been successfully tested in a computer model of AF and in a pig model . Experimental studies are now needed to determine whether similar termination mechanisms and efficacies can be observed in humans.

The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
• In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
• Patient is willing and able to cooperate with the study procedure.
• Patient is willing to provide the Informed Consent for their participation in the study.

Exclusion criteria

• Patients under 18 years or over 80 years old.
• Women who are currently pregnant or have a positive pregnancy test.
• Patients with an implantable cardiac device.
• Patients who already underwent an AF septal ablation procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Persistent and Paroxtmal AF Patients

Experimental group

Description:

Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum.

Treatment:

Procedure: Pulmonary vein ablation