Clinical trials: Heart Rhythm Disorders
Atrial Fibrillation
Microfidelity (MIFI) Ablation Technology Versus Standard Ablation Catheter for Atrioventricular Nodal Ablation
The aim of our study is to investigate the comparative efficacy of high fidelity multi electrode ablation catheters vs the standard bipolar configuration in success of AV nodal ablation This study will provide insights on the use…
- Trial name
- NCT03114124
- Testing
- MIFI Catheter, Standard Ablation Catheter
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Florida
Prolonged QT Interval in EKG and Sudden Death
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the…
- Trial name
- NCT01929083
- Testing
- Progesterone, Ibutilide
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Indiana University
Atrial Fibrillation
Specific Electrophenotypes in Atrial Fibrillation
This study will investigate a common heart rhythm disturbance (arrhythmia), atrial fibrillation (AF), to improve understanding of how best to treat it in different patients.
- Trial name
- INSPECT-AF (NCT05366530)
- Testing
- Biomarkers, electrocardiographic imaging, intracardiac electrograms, cardiac magnetic resonance imaging
- Where
- United Kingdom
- Volunteers
- 1 people
- Sponsor
- Imperial College London
Atrial Fibrillation
Cryoablation of AF: Improving the Use of the Achieve Catheter
According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins.
- Trial name
- NCT01843465
- Testing
- Maneuvers for documenting the disconnection
- Where
- France
- Volunteers
- 34 people
- Sponsor
- Clinique Pasteur
Persistent Atrial Fibrillation
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either…
- Trial name
- RAPID-AF (NCT03064451)
- Testing
- cartofinder guided ablation followed by PVI
- Where
- 7 sites in Belgium, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF…
- Trial name
- LACLOT (NCT04223505)
- Testing
- Contrast enhanced ECG-gated cardiac CT (CCT), Transesophageal Echocardiography (TEE)
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Atrial Fibrillation, Percutaneous Coronary Intervention
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate…
- Trial name
- NCT02164864
- Testing
- Dabigatran Etexilate 110mg, Warfarin 3mg, Aspirin
- Where
- 421 sites in United States, Argentina and 39 more
- Volunteers
- 2,725 people
- Sponsor
- Boehringer Ingelheim
Ventricular Tachycardia
Magnetic Stimulation to Treat VT Storm
Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource…
- Trial name
- STAR-VT (NCT04043312)
- Testing
- Magstim SuperRapid
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Pennsylvania
Atrial Fibrillation
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals
Atrial Fibrillation
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.
- Trial name
- NCT00584922
- Testing
- Endoscopy in group I (all patients)
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- University of Oklahoma
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation.
- Trial name
- NCT04130061
- Testing
- Human Amniotic Membrane
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Utah
Atrial Fibrillation
ECG App Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
- Trial name
- NCT04247581
- Testing
- 1-lead ECG
- Where
- 4 sites in United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Heart Arrhythmia
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe.
- Trial name
- PATCH (NCT04512703)
- Testing
- µCor
- Where
- Germany
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Permanent Atrial Fibrillation
Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)
Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death.
- Trial name
- RATE-AF (NCT02391337)
- Testing
- Bisoprolol, Digoxin
- Where
- 2 sites in United Kingdom
- Volunteers
- 161 people
- Sponsor
- University of Birmingham
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
Bradycardia
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation (PAF)
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens.
- Trial name
- INSTANT (NCT03539302)
- Testing
- Flecainide Acetate
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 176 people
- Sponsor
- InCarda Therapeutics, Inc.
Atrial Fibrillation
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or…
- Trial name
- ENTICED-AF (NCT02561897)
- Testing
- Edoxaban, Warfarin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Electrophysiology Research Foundation