AF Septal Pacing (Clinical Investigation Plan)

NCT03242941 | Completed Results

• 1 other identifier: AF Septal Pacing
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Localized Atrial Capture

  30 minutes

• Termination of Atrial Tachyarrhythmia.

  30 minutes

Study Arms (1)

Persistent and Paroxtmal AF Patients

EXPERIMENTAL

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.

Procedure: Pulmonary vein ablation

Interventions

Pulmonary vein ablation 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.

Persistent and Paroxtmal AF Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic BRC: lead

Study Sites (3)

Gottsegen György Országos Kardiológiai Intézet

Budapest, 1096, Hungary

Location

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, 6229 HX, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lilian Kornet
• Organization: Medtronic

lilian.kornet@medtronic.com

+31433566710

Study Officials

• Lucas V.A. Boersma

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: April 26, 2018
• Primary Completion: July 20, 2018
• Study Completion: December 21, 2018
• Last Updated: November 4, 2019
• Results First Posted: May 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); NL (2)