AF Septal Pacing (Clinical Investigation Plan)

NCT ID: NCT03242941

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2018-12-21

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

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Persistent and Paroxtmal AF Patients

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.

Group Type: EXPERIMENTAL

Pulmonary vein ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas V.A. Boersma

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Countries

Hungary; Netherlands

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AF Septal Pacing

Identifier Type: -

Identifier Source: org_study_id