Clinical trials: Phrenic Nerve Stimulation
Sleep Apnea
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
- Trial name
- MAPs (NCT01981590)
- Testing
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Where
- 2 sites in Netherlands, Sweden
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
Heart Failure
Detection of Phrenic Nerve Stimulation Using Sensors' Signals
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
- Trial name
- DETECT PS (NCT01233323)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)
The ELECtrode configuraTION CRT Study (ELECTION)
- Trial name
- ELECTION (NCT00848653)
- Testing
- CRT device
- Volunteers
- 260 people
- Sponsor
- Guidant Corporation
Heartfailure
Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.
- Trial name
- RallyX4 (NCT02066467)
- Testing
- Left Ventricular lead implant: ACUITY X4® Lead Family
- Where
- 83 sites in Austria, Belgium and 16 more
- Volunteers
- 863 people
- Sponsor
- Boston Scientific Corporation
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Neuromodulation, Phrenic Nerve Stimulation
Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve…
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Trial name
- ReInvigorate (NCT05998018)
- Testing
- pdSTIM System Therapy, Conventional Medical Management
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Stimdia Medical Inc.
Ventilator Induced Diaphragm Dysfunction
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18…
- Trial name
- RESCUE 3 (NCT03783884)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Where
- 33 sites in United States, France and 1 more
- Volunteers
- 223 people
- Sponsor
- Lungpacer Medical Inc.
Amyotrophic Lateral Sclerosis (ALS)
Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm…
- Trial name
- NCT01605006
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- 11 sites in United States
- Volunteers
- 97 people
- Sponsor
- Synapse Biomedical
Ventilator Induced Diaphragmatic Dysfunction (VIDD)
PEPNS System Feasibility Study
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
- Trial name
- NCT03559933
- Testing
- PEPNS System
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 12 people
- Sponsor
- Stimdia Medical Inc.
Heart Failure
Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.
- Trial name
- Efface (NCT01244308)
- Where
- 10 sites in Germany
- Volunteers
- 132 people
- Sponsor
- Abbott Medical Devices
Sleep Disordered Breathing, Cheyne-Stokes Respiration
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas).
- Conditions
- Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea
- Trial name
- NCT00909259
- Testing
- Phrenic stimulation device
- Where
- 5 sites in United States, China and 1 more
- Volunteers
- 50 people
- Sponsor
- Respicardia, Inc.
Healthy Subjects, Elective Surgical Procedure
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized…
- Trial name
- NCT04884698
- Testing
- Stimit Activator
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Stimit AG
Heart Failure
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
- Trial name
- ORPHEE (NCT03127202)
- Testing
- Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
- Where
- 12 sites in France
- Volunteers
- 90 people
- Sponsor
- LivaNova
Ventilator Induced Diaphragm Dysfunction
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned.
- Trial name
- AERO-PAS (NCT07477054)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Volunteers
- 120 people
- Sponsor
- Lungpacer Medical Inc.
Heart Failure
Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads
Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony.
- Trial name
- EffaceQ (NCT01484613)
- Testing
- quadripolar LV lead (Quartet)
- Where
- 16 sites in Germany
- Volunteers
- 337 people
- Sponsor
- Abbott Medical Devices
Diaphragm Issues
STIMIT Activator 1 IDE Study
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been…
- Trial name
- NCT05883163
- Testing
- Stimit Activator 1
- Where
- 4 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Stimit AG
Heart Failure
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.
- Trial name
- PING-EP (NCT01109641)
- Testing
- diagnostic electrophysiology catheter
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Medtronic Italia
Postoperative Cardiac Complication, Heart Failure
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and…
- Conditions
- Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation
- Trial name
- MORE-CRT (NCT01510652)
- Testing
- BiP Group, Quad Group
- Where
- 64 sites in Belgium, Canada and 11 more
- Volunteers
- 1,078 people
- Sponsor
- Abbott Medical Devices