Clinical trials: Syncope and Collapse
Acute Coronary Syndromes, Heart Failure
Registry Of Acute meDical Emergencies in Brazil
Critical patients in emergency room are seriously situations that need quickly diagnosis and treatment. Different predictors of prognosis can be related with mortality and morbidity in-hospital and in long-term.
- Conditions
- Acute Coronary Syndromes, Heart Failure, Pulmonary Edema, Aortic Aneurysm, Familial Thoracic 1
- Trial name
- ROAD-Brazil (NCT02753023)
- Testing
- no intervention
- Where
- 6 sites in Brazil
- Volunteers
- 1,650 people
- Sponsor
- University of Sao Paulo General Hospital
Sleep Syncope
Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)
At least 5% of patients with vasovagal syncope also have Sleep Syncope. Patients awake from sleep with profound malaise and gastrointestinal vagal symptoms. About 75% have severe nausea and about 40% have lower abdominal cramps.
- Trial name
- POST9 (NCT05657925)
- Testing
- ondansetron 8 mg
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- University of Calgary
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Postural Orthostatic Tachycardia Syndrome
A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
POTS is a relatively common condition that affects millions of patients around the globe. It has an estimated prevalence of 170/100,000 with approximately 80% of patients being women of childbearing age.
- Trial name
- NCT03365414
- Testing
- Albumin (Human) 5%, USP, Normal Saline 0.9% Infusion Solution Bag
- Sponsor
- University of Alberta
Arrhythmia
Study Evaluating GAP-486 in Heart Rhythm
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.
- Trial name
- NCT00137293
- Testing
- GAP-486 (ZP-123), 0.9% Sodium Chloride, USP
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Syncope, Recurrent Symptomatic Atrial Fibrillation
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
- Trial name
- NCT01965899
- Testing
- Insertable Cardiac Monitor Implant
- Where
- 16 sites in Australia, Austria and 5 more
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
Neurocardiogenic Syncope, Vasovagal Syncope
Cardioneuroablation for Neurocardiogenic Syncope
The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the treatment of neurocardiogenic syncope (NCS), also known as "vaso-vagal" syncope.
- Trial name
- Ablate-NCS (NCT02009982)
- Testing
- Cardioneuroablation, Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- David B. De Lurgio
Atrial Fibrillation, Syncope
Remote Symptom Review in Patients With Implantable Diagnostic Holter
To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by…
- Conditions
- Atrial Fibrillation, Syncope, Bradycardia, Arrythmia
- Trial name
- BIOMONI-DIG (NCT06431828)
- Testing
- APP
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Andres Iñiguez Romo
Syncope
NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness
This study is designed to evaluate the accuracy of the National Institute for Health and Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short term serious outcome when presenting in the…
- Trial name
- NCT01498471
- Where
- Belgium
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Neurally Mediated Syncope
The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.
- Trial name
- SHAM-ROX NMS (NCT02388087)
- Testing
- ROX COUPLER, Right heart catheterisation and routine care
- Volunteers
- 20 people
- Sponsor
- East Sussex Healthcare NHS Trust
Syncope
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life.
- Trial name
- NCT04252729
- Testing
- Psychotherapy
- Where
- Brazil
- Volunteers
- 10 people
- Sponsor
- Mauricio Ibrahim Scanavacca
Migraine
The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
This is a study to compare subject response and symptoms resulting from administration of three clinical assessments. The 3 assessments are 1. passive upright tilt table testing, 2.
- Trial name
- NCT01080287
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The Cleveland Clinic
Vasovagal Syncope
Study of Atomoxetine in the Prevention of Vasovagal Syncope
Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical…
- Trial name
- POST7 (NCT05159687)
- Testing
- Atomoxetine Hydrochloride
- Where
- Canada
- Volunteers
- 180 people
- Sponsor
- University of Calgary
Implantable Loop Recorder
Bradycardia Risk Stratification With Loop Recorder After Syncope
Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder.
- Trial name
- NCT04200014
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Central Hospital, Nancy, France
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
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Syncope
International Study on Syncope of Uncertain Etiology
This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loop Recorder (ILR)implantation.
- Trial name
- NCT00120094
- Where
- 3 sites in Italy, United Kingdom
- Volunteers
- 400 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices