Clinical trial NCT03242941: AF Septal Pacing (Clinical Investigation Plan)
Official title: AF Septal Pacing (Clinical Investigation Plan)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Electrodes in a Stable Position
timeFrame: 30 minutes
Secondary outcomes:
measure: Localized Atrial Capture
timeFrame: 30 minutes
measure: Termination of Atrial Tachyarrhythmia.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: St. Antonius Hospital
name: Lucas V.A. Boersma
role: PRINCIPAL_INVESTIGATOR
References: