Clinical trials: Syncope
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Postural Orthostatic Tachycardia Syndrome, Chronic Orthostatic Intolerance
Using Mirabegron to Increase BP in Patients With POTS
This is a pilot dose-finding study to test the hypothesis that mirabegron increases systolic blood pressure (BP), prevents syncope/presyncope, and improves the quality of life (QOL), functional capacity, chest pain, and…
- Conditions
- Postural Orthostatic Tachycardia Syndrome, Chronic Orthostatic Intolerance, Syncope
- Trial name
- RAISE-BP (NCT06133075)
- Testing
- Mirabegron 50 MG, Mirabegron 25 MG
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Syncope
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
- Trial name
- NCT00359203
- Testing
- Dual chamber pacemeker
- Where
- Italy
- Volunteers
- 511 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Diabetic Retinopathy, Macular Degeneration
Advancing Understanding of Transportation Options
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers.
- Conditions
- Diabetic Retinopathy, Macular Degeneration, Glaucoma, Retinitis Pigmentosa
- Trial name
- AUTO (NCT04141891)
- Testing
- Driving Decision Aid, Older Drivers Website
- Where
- 3 sites in United States
- Volunteers
- 529 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Syncope, Syncope, Vasovagal
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing.
- Trial name
- BIO|Sync-HUTT (NCT06038708)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Biotronik SE & Co. KG
Drug Resistant Epilepsy, Drop Seizures
Novel Helmet Design in Patients With Seizures
This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.
- Conditions
- Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure, Complex Partial Seizure
- Trial name
- NCT03443388
- Testing
- Hövding inflatable helmet
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Michael A. Gelfand, MD, PhD
Tachyarrhythmia, Atrial Fibrillation (AF)
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk…
- Conditions
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
- Trial name
- NCT04025710
- Testing
- BIOMONITOR III and BIOMONITOR IIIm
- Where
- 27 sites in Australia, Austria and 4 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Syncope
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM)…
- Conditions
- Atrial Fibrillation, Syncope, Cryptogenic Stroke
- Trial name
- LUX-Dx PERFORM (NCT04732728)
- Where
- 24 sites in United States
- Volunteers
- 727 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Syncope, Vasovagal
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery.
- Trial name
- NCT04972123
- Testing
- CPC - Capsaicin, Phenylephrine, Caffeine, Tilt Table Test
- Where
- United States
- Volunteers
- 143 people
- Sponsor
- University of Wisconsin, Madison
Syncope, Vasovagal
Presyncope (Syncope) Prevention Study
This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and…
- Trial name
- PS^2 (NCT04772755)
- Testing
- Buzzy® and Electronic Game
- Where
- 2 sites in United States
- Volunteers
- 338 people, healthy volunteers welcome
- Sponsor
- Duke University
Syncope
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
- Trial name
- ASAP (NCT02188147)
- Testing
- Short Term Wearable Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zoll Medical Corporation
Symptomatic Neurogenic Orthostatic Hypotension, MSA
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, MSA, Parkinson's Disease (PD), Pure Autonomic Failure (PAF)
- Trial name
- REDWOOD (NCT03829657)
- Testing
- ampreloxetine
- Where
- 82 sites in United States, Australia and 17 more
- Volunteers
- 203 people
- Sponsor
- Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
- Trial name
- OAK (NCT04095793)
- Testing
- ampreloxetine
- Where
- 55 sites in United States, Australia and 16 more
- Volunteers
- 110 people
- Sponsor
- Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.
- Trial name
- SEQUOIA (NCT03750552)
- Testing
- ampreloxetine
- Where
- 125 sites in United States, Australia and 17 more
- Volunteers
- 195 people
- Sponsor
- Theravance Biopharma
Sick Sinus Syndrome, Complete Heart Block
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or…
- Conditions
- Sick Sinus Syndrome, Complete Heart Block, Syncope, Chronic Systolic Heart Failure
- Trial name
- ENVELOPE (NCT02809131)
- Testing
- polymixin/bacitracin, cephalexin, or levofloxacin, or clindamycin, Saline
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Vanderbilt University Medical Center
Syncope
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences.
- Trial name
- BIOSync CLS (NCT02324920)
- Testing
- DDD-CLS, ODO
- Where
- 24 sites in Canada, France and 4 more
- Volunteers
- 128 people
- Sponsor
- Biotronik SE & Co. KG
Bifascicular Block, Syncope
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Study Objective The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.
- Trial name
- PRESS (NCT01463358)
- Testing
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Where
- 12 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Boston Scientific Corporation
Pulmonary Arterial Hypertension
Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients
This was a non-confirmatory, randomized, placebo controlled, subject and investigator blinded study of QCC374 in PAH subjects. The study was planned to have 2 Parts: Part 1, an initial safety cohort with a 0.03 mg bid starting…
- Trial name
- NCT02927366
- Testing
- QCC374
- Where
- 5 sites in United States, Germany and 2 more
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals