Clinical trials: Cardiac Rhythm Disorder
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Postural Orthostatic Tachycardia Syndrome
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans, but predominates in women with a 5:1 ratio.
- Trial name
- POTS (NCT03182725)
- Testing
- Ivabradine
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of California, San Diego
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmias, Cardiac
X-ray Dose Reduction in Electrophysiology
Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01593852
- Testing
- Advanced image processing, Regular image processing
- Where
- Netherlands
- Volunteers
- 136 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Medical Need of OAC Reversal
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
- Trial name
- NCT03254147
- Testing
- warfarin, dabigatran, Apixaban
- Where
- Japan
- Volunteers
- 53,969 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation
Atrial fibrillation (AF), the most common sustained heart rhythm disorder, is becoming increasingly prevalent in the Western world.
- Trial name
- NCT01719367
- Testing
- Atenolol
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Vanderbilt University Medical Center
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University
Atrial Fibrillation, Thromboembolism
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects.
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Trial name
- Amulet™PMS (NCT02447081)
- Testing
- Subjects implanted with Amulet Device
- Where
- 51 sites in Australia, Belgium and 14 more
- Volunteers
- 1,088 people
- Sponsor
- Abbott Medical Devices
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
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting.
- Trial name
- ENTRUST-AF-PCI (NCT02866175)
- Testing
- Edoxaban, Clopidogrel, Prasugrel
- Where
- 200 sites in Austria, Belgium and 16 more
- Volunteers
- 1,506 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Ventricular Fibrillation, Ventricular Tachycardia
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock…
- Trial name
- iD-System (NCT04011631)
- Testing
- Internal defibrillation during cardiac surgery, using the iD-system
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- SMART Clinical Products BV
Atrial Fibrillation
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are…
- Trial name
- PINNACLE FLX (NCT02702271)
- Testing
- WATCHMAN FLX
- Where
- 29 sites in United States
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
AV Block, AV Block Complete
Accelerometer Sensing for Micra AV Study
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
- Conditions
- AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
- Trial name
- AccelAV (NCT04245345)
- Testing
- Accelerometer Sensing for Micra AV Study
- Where
- 20 sites in United States, Hong Kong
- Volunteers
- 157 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).
- Trial name
- NCT00958165
- Testing
- CardioFocus EAS-AC
- Where
- 3 sites in Germany
- Volunteers
- 81 people
- Sponsor
- CardioFocus
Tachycardia, Atrioventricular Nodal Reentry
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with…
- Trial name
- PS-010 (NCT00621621)
- Testing
- Freezor® Cardiac Cryoablation Catheter CryoConsole System
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the…
- Trial name
- RHYTHM-AF (NCT01119716)
- Volunteers
- 4,658 people
- Sponsor
- Merck Sharp & Dohme LLC
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health…
- Trial name
- NCT03572972
- Testing
- Apixaban, Dabigatran, Rivaroxaban
- Where
- South Korea
- Volunteers
- 64,684 people
- Sponsor
- Pfizer
Atrial Fibrillation, Medication Adherence
Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).
- Trial name
- NCT02690649
- Testing
- Health Messaging (Non-Procedural)
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Tammy Toscos