Trial Outcomes & Findings for AF Septal Pacing (Clinical Investigation Plan) (NCT NCT03242941)

Last Updated: 2019-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

30 minutes

Results posted on

2019-11-04

Participant Flow

If the pulmonary vein ablation succeeded and the subject was in sinus rhythm the study procedure started from the electrode testing. Alternatively, if the subject was still in AF, the electrode testing was performed after either the application of the dual stage pacing algorithm or the cardioversion, when the sinus rhythm was established.

Participant milestones

Participant milestones
Measure	Persisten and Paroxymal 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. 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 will be assessed as well as AF termination.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AF Septal Pacing (Clinical Investigation Plan)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paroxymal and Persistent AF Patients n=14 Participants 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. 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 will be assessed as well as AF termination.
Age, Continuous	55 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Height	182 cm STANDARD_DEVIATION 14 • n=5 Participants
Weight	92 kg STANDARD_DEVIATION 20 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: The maximum number of electrode pairs used and potentially stable

Outcome measures

Outcome measures
Measure	Paroxymal and Persistent AF Patients n=60 Electrode pairs 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. 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 will be assessed as well as AF termination.
Number of Electrodes in a Stable Position	38 Electrode pairs

SECONDARY outcome

Timeframe: 30 minutes

Population: Patient treated with the new pacing scheme algorithm

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

Outcome measures

Outcome measures
Measure	Paroxymal and Persistent AF Patients n=14 Episodes 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. 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 will be assessed as well as AF termination.
Localized Atrial Capture	8 Episodes

SECONDARY outcome

Timeframe: 30 minutes

Population: Patients treated with the new dual stage pacing algorithm

Termination of atrial tachyarrhythmia.

Outcome measures

Outcome measures
Measure	Paroxymal and Persistent AF Patients n=14 AF termination occurrence 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. 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 will be assessed as well as AF termination.
Termination of Atrial Tachyarrhythmia.	3 AF termination occurrence

Adverse Events

Paroxymal and Persistent AF Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Paroxymal and Persistent AF Patients n=14 participants at risk 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. 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 will be assessed as well as AF termination.
Cardiac disorders pericardial effusion	7.1% 1/14 • Number of events 1 • Since AF Septal Pacing is an acute study with no follow up and patient exit at the end of the procedure, only AE occurred during the procedure were recorded. Adverse Events were evaluated according to ISO 14155:2011

Additional Information

Lilian Kornet

Medtronic

Phone: +31433566710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place