Clinical trials: Phrenic Nerves
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 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
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation
- Trial name
- ROSTER (NCT07907068)
- Testing
- Phrenic nerve stimulation
- Volunteers
- 300 people
- Sponsor
- Zoll Medical 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
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.
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and…
- Trial name
- RESCUE1 (NCT03107949)
- Testing
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator-Induced Lung Injury
Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
- Trial name
- NCT03659552
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
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
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
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Lungpacer Medical Inc.
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
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
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts.
- Trial name
- RESCUE2 (NCT03096639)
- Testing
- Diaphragmatic Pacing Therapy DPTS
- Where
- 21 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- Lungpacer Medical Inc.
Atrial Fibrillation
First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation
The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation.
- Trial name
- SAFE-CMAP (NCT07820631)
- Testing
- Circle Safe System Use During Pulmonary Vein Ablation
- Where
- 4 sites in France, New Zealand
- Volunteers
- 50 people
- Sponsor
- Circle Safe, Inc.
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
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.
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.
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 Lung Injury
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
- Trial name
- NCT02670460
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 24 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.
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