NCT03242941

AF Septal Pacing (Clinical Investigation Plan)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein ablation	After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.

Timeline

• Start date: 2018-04-26
• Primary completion: 2018-07-20
• Completion: 2018-12-21
• First posted: 2017-08-08
• Last updated: 2019-11-04
• Results posted: 2019-05-20

Locations

3 sites across 2 countries: Hungary, Netherlands