AF Septal Pacing (Clinical Investigation Plan)

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

AF Septal Pacing (Clinical Investigation Plan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242941
• Other study ID #: AF Septal Pacing
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: October 2019
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 21, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Electrodes in a Stable Position	To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.	30 minutes
Secondary	Localized Atrial Capture	To assess Localized Atrial Capture the following endpoints will be considered: - the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions	30 minutes
Secondary	Termination of Atrial Tachyarrhythmia.	Termination of atrial tachyarrhythmia.	30 minutes