Clinical trials: Arrhythmias
Atrial Fibrillation
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin.
- Trial name
- ENSURE-AF (NCT02072434)
- Testing
- Edoxaban, Warfarin, Enoxaparin
- Where
- 228 sites in United States, Austria and 17 more
- Volunteers
- 2,199 people
- Sponsor
- Daiichi Sankyo
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
Sudden Cardiac Death, Ventricular Fibrillation
LifeVest Post-CABG Registry
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease…
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction
- Trial name
- NCT01448005
- Testing
- wearable defibrillator (LifeVest)
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Zoll Medical Corporation
Atrial Fibrillation
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- NCT01824394
- Testing
- nMARQ Navigation Catheters, NaviStar ThermoCool Catheters
- Volunteers
- 481 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT05773170
- Testing
- Refralon
- Where
- 33 sites in Russia
- Volunteers
- 1,147 people
- Sponsor
- R-Pharm
Heart Diseases, Rhythm; Abnormal
BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)
Collection of Holter surface ECGs for the development of new sensing and detection algorithms
- Trial name
- NCT04243070
- Testing
- 3-channel Holter ECG recording, 12-channel Holter ECG recording
- Where
- 5 sites in Germany
- Volunteers
- 89 people
- Sponsor
- Biotronik SE & Co. KG
Fibrillation, Atrial, Atrial Fibrillation
Odiparcil QT Definitive Study
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.
- Trial name
- NCT00437242
- Testing
- Odiparcil
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cardiac Arrhythmia
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.
- Trial name
- BIO|COLLECT-EP (NCT05560958)
- Testing
- BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
- Where
- Germany
- Volunteers
- 280 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Surgery
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a…
- Conditions
- Atrial Fibrillation, Surgery, Ablation of Atrial Fibrillation, Clamp Study
- Trial name
- NCT06355063
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 6 sites in Austria, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Pulse Biosciences, Inc.
Ventricular Tachycardia, Ventricular Fibrillation
Leader - Evaluation of Endotak Reliance
The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.
- Trial name
- NCT00180349
- Testing
- Endotak Reliance
- Where
- 25 sites in France
- Volunteers
- 904 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia, Atrial Fibrillation
BIO.MASTER.BioMonitor 2 Study
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
- Conditions
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- Trial name
- NCT02565238
- Testing
- BioMonitor 2
- Volunteers
- 92 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Atrial Flutter
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
- Trial name
- CryoCure2 (NCT02839304)
- Testing
- Cryoablation System
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 80 people
- Sponsor
- Adagio Medical
Fibrillation, Atrial
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
- Trial name
- NCT00402363
- Testing
- omega-3-acid ethyl esters
- Where
- 178 sites in United States
- Volunteers
- 663 people
- Sponsor
- GlaxoSmithKline
Pacemaker, Bradycardia
Adapta Pacing System Clinical Study
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow).
- Trial name
- NCT00307073
- Testing
- Implantable Pulse Generator
- Where
- 7 sites in Austria, Czechia and 4 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Healthy Chinese Subjects
A Study of Etripamil in Healthy Subjects
The objectives of the study are as below: Primary: ·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects Secondary: To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese…
- Trial name
- NCT05511870
- Testing
- Etripamil Nasal Spray 70mg
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Arrhythmia, Heart Failure
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.
- Trial name
- 4968 (NCT01076361)
- Where
- 106 sites in United States, Australia and 12 more
- Volunteers
- 370 people
- Sponsor
- Medtronic
Sinus Node Disease, Atrioventricular Block
BIO|STREAM.CSP CLS
This clinical study is a prospective, observational submodule of the BIO|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system…
- Trial name
- NCT07608822
- Testing
- Left bundle branch area pacing with Closed Loop Stimulation
- Where
- 12 sites in Czechia, Hungary and 3 more
- Volunteers
- 150 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Atrial Flutter
Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
The primary purpose of this study is to optimize drug exposure in the target population.
- Trial name
- NCT01229254
- Testing
- Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg
- Volunteers
- 189 people
- Sponsor
- Portola Pharmaceuticals
Sinus Node Dysfunction, Atrioventricular Block
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode
Observational study on long PR interval using the SafeR mode in bradycardia patients.
- Trial name
- PRECISE (NCT02586480)
- Testing
- dual chamber pacemaker with SafeR algorithm
- Where
- 58 sites in France
- Volunteers
- 848 people
- Sponsor
- LivaNova
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