Clinical trials: Cardiac Arrhythmia
Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for…
- Trial name
- PULSED AF (NCT04198701)
- Testing
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 421 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
- Trial name
- PULSE-EU (NCT05164107)
- Testing
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
- Where
- Czechia
- Volunteers
- 175 people
- Sponsor
- Kardium Inc.
Premature Ventricular Contractions, Ventricular Tachycardia
CHU Dual-Energy Ablation in Ventricular Arrhythmia
The objective of this study is to evaluate the safety of the dual-energy ablation catheter manufactured by Shanghai MicroPort EP Medical Technology Co., Ltd. in the treatment of tachyarrhythmias.
- Trial name
- CHU-VA (NCT07503769)
- Testing
- ablation
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Atrial Flutter
A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
- Trial name
- Scene 2 (NCT00476112)
- Testing
- Vernakalant Injection 20 mg/mL
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Advanz Pharma
Arrhythmias, Cardiac
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
- Trial name
- NCT01000532
- Testing
- SIELLO JT/T, Pacemaker therapy, BPPU JT/T
- Where
- Hungary
- Volunteers
- 88 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmias
Non Invasive Arrhythmia Detection in Hospital Settings
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.
- Trial name
- EVE (NCT00919087)
- Testing
- Avivo System
- Volunteers
- 25 people
- Sponsor
- Corventis, Inc.
Atrial Fibrillation
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
- Trial name
- SpherePVI (NCT05115214)
- Testing
- SpherePVI™ Catheter
- Where
- 2 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Percutaneous Coronary Intervention
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT)…
- Trial name
- PIONEER AF-PCI (NCT01830543)
- Testing
- rivaroxaban 2.5 mg, rivaroxaban 15 mg, rivaroxaban 10 mg
- Where
- 348 sites in United States, Argentina and 23 more
- Volunteers
- 2,124 people
- Sponsor
- Janssen Scientific Affairs, LLC
Ventricular Tachycardia
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent…
- Trial name
- NCT06384599
- Testing
- VT Cryoablation System
- Where
- United Kingdom
- Volunteers
- 130 people
- Sponsor
- Adagio Medical
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation
The Study for Evaluate of Safety and Efficacy of Vein of Marshall RF Ablation
The goal of this clinical trial is to evaluate the initial safety and effectiveness of an investigational medical device. Electrode catheter ablation of the Marshall vein is performed using TIRA, a clinical trial medical device…
- Trial name
- NCT05854238
- Testing
- TIRA-VoM
- Where
- 2 sites in South Korea
- Volunteers
- 4 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Atrial Fibrillation, Persistent or Longstanding Persistent Atrial Fibrillation
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial…
- Trial name
- DEEP (NCT02393885)
- Testing
- AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
- Where
- 17 sites in United States, Belgium and 1 more
- Volunteers
- 90 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Tailored Treatment of Permanent Atrial Fibrillation
The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
- Trial name
- TTOP-AF (NCT00514735)
- Testing
- Medtronic Cardiac Ablation System, Class I or III Antiarrhythmic Medications
- Where
- 24 sites in United States, Netherlands
- Volunteers
- 210 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain
Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice
- Trial name
- HEROIC (NCT02262676)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Spain
- Volunteers
- 2,251 people
- Sponsor
- Bayer
Atrial Fibrillation, Atrial Flutter
HeartBeam ECG Registry
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia
- Trial name
- NCT07501299
- Testing
- Electrocardiogram (ECG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- HeartBeam, Inc.
Bradycardia, Atrioventricular Block
BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area.
- Conditions
- Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
- Trial name
- BIO-CONDUCT (NCT05251363)
- Testing
- Solia S lead
- Where
- 14 sites in United States
- Volunteers
- 194 people
- Sponsor
- Biotronik, Inc.
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
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
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