Trial Outcomes & Findings for Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (NCT NCT01981590)

Results Overview

Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

one hour

Results posted on

2020-03-16

Participant Flow

15 subjects have been enrolled, in Sweden (Karolinska University Hospital, Solna in Stockholm) and in The Netherlands (Catherina Hospital in Eindhoven). All the 15 subjects enrolled underwent the study procedure and performed the 2-4 weeks post-procedure assessment follow-up

Participant milestones

Participant milestones
Measure	Phrenic Nerve Stimulation Intravenously stimulating the phrenic nerve Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phrenic Nerve Stimulation n=15 Participants Intravenously stimulating the phrenic nerve Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age, Continuous	60 years STANDARD_DEVIATION 8 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Region of Enrollment Sweden	7 participants n=93 Participants
Region of Enrollment Netherlands	8 participants n=93 Participants

PRIMARY outcome

Timeframe: one hour

Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure

Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less

Outcome measures

Outcome measures
Measure	Patients With Phrenic Nerve Stimulation Achieved n=15 Participants Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)	15 Participants

SECONDARY outcome

Timeframe: one hour

Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure

Number of Patients With Response to Stimulation, defined by measured tidal volume of 200 ml or more induced by a pacing stimulus with pulse amplitude of 4 V or less

Outcome measures

Outcome measures
Measure	Patients With Phrenic Nerve Stimulation Achieved n=15 Participants Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Number of Patients With Response to Stimulation (Tidal Volume)	9 Participants

SECONDARY outcome

Timeframe: From procedure to 2-4 weeks post-procedure

Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure

Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation

Outcome measures

Outcome measures
Measure	Patients With Phrenic Nerve Stimulation Achieved n=15 Participants Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Number of Patients With Observed Side Effects	6 Participants

SECONDARY outcome

Timeframe: From procedure to 2-4 weeks post-procedure

Population: All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure

All observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation such as pain, hiccup, skeletal muscular tremor, nausea, and sinus node activation

Outcome measures

Outcome measures
Measure	Patients With Phrenic Nerve Stimulation Achieved n=15 Participants Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Number of Observed Side Effects	7 Side Effect

Adverse Events

Phrenic Nerve Stimulation

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phrenic Nerve Stimulation n=15 participants at risk Intravenously stimulating the phrenic nerve Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Cardiac disorders Atrial fibrillation	6.7% 1/15 • Number of events 1 • From procedure to 2-4 weeks post-procedure
Cardiac disorders Sinus node dysfunction	6.7% 1/15 • Number of events 1 • From procedure to 2-4 weeks post-procedure
Vascular disorders Peripheral artery aneurysm	6.7% 1/15 • Number of events 1 • From procedure to 2-4 weeks post-procedure

Other adverse events

Other adverse events
Measure	Phrenic Nerve Stimulation n=15 participants at risk Intravenously stimulating the phrenic nerve Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.: Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
Cardiac disorders Atrial fibrillation	13.3% 2/15 • Number of events 2 • From procedure to 2-4 weeks post-procedure
Cardiac disorders Supraventricular tachycardia	6.7% 1/15 • Number of events 1 • From procedure to 2-4 weeks post-procedure
Cardiac disorders Sinus node dysfunction	6.7% 1/15 • Number of events 1 • From procedure to 2-4 weeks post-procedure

Additional Information

Lilian Kornet, Prin.Scientist

Medtronic Bakken Research Center

Phone: +31433566710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place