Clinical trials: Arrhythmias
Atrial Fibrillation
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF)…
- Trial name
- NCT02348723
- Testing
- Warfarin, Dabigatran Etexilate 150mg
- Where
- 87 sites in United States, Belgium and 9 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.
- Trial name
- SYNCHRO (NCT02870647)
- Testing
- Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
- Where
- 3 sites in Italy, Spain
- Sponsor
- LivaNova
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Tachycardia, Ventricular
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
The objective of this clinical investigation is to evaluate: 1. the safety and efficacy of the CyberHeart System, CardioPlan™ Software and Laptop, in treating patients with refractory ventricular tachycardia (VT) using the…
- Trial name
- NCT02661048
- Testing
- CyberHeart System
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Varian, a Siemens Healthineers Company
Atrial Fibrillation, Stroke
Amplatzer Amulet LAAO vs. NOAC
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CATALYST (NCT04226547)
- Testing
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
- Where
- 127 sites in United States, Australia and 14 more
- Volunteers
- 2,650 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Arrhythmia
VOLta Medical AI-software in REal-World During AF Ablation
This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping…
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac
- Trial name
- VOLTAIRE-AF (NCT07621055)
- Testing
- Cardiac mapping
- Where
- 3 sites in France
- Volunteers
- 150 people
- Sponsor
- Volta Medical
Atrial Fibrillation
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more.
- Trial name
- NCT02090543
- Testing
- Phenprocoumon (Marcumar), Rivaroxaban (Xarelto, BAY-59 7939)
- Where
- Germany
- Volunteers
- 647 people
- Sponsor
- Bayer
Atrial Fibrillation
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm).
- Trial name
- X-VERT (NCT01674647)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- Where
- 178 sites in United States, Belgium and 15 more
- Volunteers
- 1,504 people
- Sponsor
- Bayer
Atrial Fibrillation
Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes
Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart.
- Trial name
- NCT02964949
- Testing
- Edoxaban
- Where
- 233 sites in Belgium, Bulgaria and 13 more
- Volunteers
- 607 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
- Trial name
- ASAP (NCT00851578)
- Testing
- WATCHMAN
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 150 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular…
- Trial name
- LESS-VT (NCT03490201)
- Testing
- Market Approved RF Ablation System, FlexAbility SE Ablation Catheter
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 592 people
- Sponsor
- Abbott Medical Devices
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential…
- Trial name
- Star AF II (NCT01203748)
- Testing
- PVI + Lines ablation, PVI, PVI + CFE ablation
- Where
- 2 sites in Australia, Canada
- Volunteers
- 589 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
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
Atrial Fibrillation
Atrial Fibrillation Screening With a Smartphone Device and iECG Application
Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool? Objectives: Detection…
- Trial name
- AFScreenCol (NCT02534532)
- Testing
- AF screening
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bayer
Atrial Fibrillation
Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II)
The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa…
- Trial name
- ORBIT-AF II (NCT01701817)
- Testing
- Patients with Atrial Fibrillation
- Where
- 219 sites in United States, Puerto Rico and 1 more
- Volunteers
- 13,769 people
- Sponsor
- Janssen Scientific Affairs, LLC
Ventricular Tachycardia, Ventricular Fibrillation
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrillator system (S-ICD).
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- FACTS (NCT01161589)
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 142 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).
- Trial name
- NCT00157248
- Testing
- dabigatran etexilate
- Where
- 50 sites in United States, Denmark and 2 more
- Volunteers
- 361 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation
Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives.
- Trial name
- SILVERCARE_AF (NCT05804747)
- Testing
- Edoxaban
- Where
- 33 sites in South Korea
- Volunteers
- 1,204 people
- Sponsor
- Daiichi Sankyo
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