Clinical trials: Arrhythmias
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch
Ventricular Tachycardia
Abbott Ventricular Tachycardia PAS
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of…
- Trial name
- NCT05839873
- Testing
- FlexAbility SE Ablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 62 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Tachycardia
China 3T MRI Study
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans.
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Trial name
- NCT06038123
- Testing
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Where
- 5 sites in China
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrhythmia
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing…
- Trial name
- TEMPO (NCT02104583)
- Testing
- Eleclazine
- Where
- 84 sites in United States, Canada and 7 more
- Volunteers
- 313 people
- Sponsor
- Gilead Sciences
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Retrospective Registry Providing Baseline Data on the Outcome of Left Atrial (LA) or LA Appendage (LAA) Thrombus in Patients With Nonvalvular Atrial Fibrillation (AF) or Atrial Flutter After Standard of Care (SoC) Anticoagulant Therapy
Thrombus outcome data will be collected retrospectively during 2011-2012 as a historical baseline of SoC with oral VKA (Vitamin K Antagonist(s) for the treatment of patients with nonvalvular AF or atrial flutter documented with…
- Trial name
- CLOT-AF (NCT01928979)
- Testing
- no drug
- Where
- 7 sites in Bulgaria, France and 5 more
- Volunteers
- 160 people
- Sponsor
- Bayer
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Atrial Fibrillation, Syncope
BIO|CONCEPT.BIOMONITOR III
The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the…
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Trial name
- NCT03850327
- Testing
- BIOMONITOR III
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation System in accessing and closing off the left atrial appendage (LAA) using a minimally invasive epicardial access approach.
- Trial name
- LASSO-AF (NCT02583178)
- Testing
- Aegis Sierra Ligation System
- Where
- 7 sites in United States, Canada
- Volunteers
- 7 people
- Sponsor
- Aegis Medical Innovations
Myocardial Infarction, Arrhythmia, Ventricular
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305240
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 656 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based…
- Trial name
- ELIMINATE-AF (NCT02942576)
- Testing
- Edoxaban, VKA-Based Regimen
- Where
- 75 sites in Belgium, Canada and 9 more
- Volunteers
- 632 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Bradycardia, Chronotropic Incompetence
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
This study will collect data on features for future pacemakers via an external non-implantable system.
- Trial name
- COGNATE (NCT01030705)
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Arrhythmias, Cardiac
CanGaroo® Registry Study
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
- Trial name
- NCT04846127
- Testing
- CanGaroo Envelope
- Where
- 23 sites in United States
- Volunteers
- 500 people
- Sponsor
- Elutia Inc.
Arrhythmia
Electrocardiogram (ECG) Recordings in Paediatric Population
The primary goal of this protocol is to collect ECG signals from paediatric patients using 4 surface electrodes placed in the configurations proposed for the Cameron Health, Inc.
- Trial name
- NCT00399386
- Testing
- EP, ICD, Ablation
- Where
- United Kingdom
- Volunteers
- 62 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an…
- Trial name
- aMAZE (NCT02513797)
- Testing
- LARIAT + PVI, Pulmonary Vein Isolation
- Where
- 53 sites in United States
- Volunteers
- 600 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Premature Beats
To Evaluate the Efficacy and Safety of Wenxin Keli in Treating Atrial Premature Beats
A randomized, double-blind, two dose group, parallel-control multi-center, post-marketing clinical trial，to evaluate the efficacy and safety of Wenxin keli in treating atrial premature beats by different dose,to provide a…
- Trial name
- NCT02319603
- Testing
- Low dose WenXin keli, High dose WenXin keli
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Beijing Bozhiyin T&S Co., Ltd.
Atrial Fibrillation
The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation
Optical sensing technologies have the potential to enable long-term heart rhythm monitoring. The medically certified and clinically validated FibriCheck technology has proven its value for spot-check measurements to detect AF.
- Trial name
- FLASH-AF (NCT03620656)
- Testing
- FibriCheck
- Where
- Belgium
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Qompium NV
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