Clinical trials: Arrhythmia, active
Persistent Atrial Fibrillation
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
- Trial name
- ReMATCH (NCT06735534)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 376 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrhythmia
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Background: Ventricular arrhythmia is an abnormal pulse rhythm that starts in the lower part of the heart (ventricles). Treatment includes ablation; ablation uses heat to destroy small portions of the heart that are causing short…
- Trial name
- NCT06940752
- Testing
- VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ventricular Arrhythmia
EDEN Intracardiac Electrogram Recording and Classifying System
Background: Heart surgeons use electrocardiogram (ECG) machines to record electrical signals from the heart during procedures. Normal ECG machines connect only to the skin.
- Trial name
- NCT07137455
- Testing
- EDEN Intracardiac Electrogram Recording and Classifying System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ventricular Arrhythmias
Pulsed Field Ablation for Ventricular Arrhythmias
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of pulsed field ablation for the treatment of ventricular arrhythmias.
- Trial name
- NCT07727330
- Testing
- Pulsed Field Ablation
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xi'an Jiaotong University
Atrial Fibrillation, Atrial Flutter
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- Trial name
- ANGEL-AF (NCT07210151)
- Testing
- VERAFEYE Anatomic Guidance System
- Where
- 4 sites in Croatia, Czechia and 1 more
- Volunteers
- 50 people
- Sponsor
- LUMA Vision Ltd.
Atrial Arrhythmia, Intracardiac Echocardiography
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most…
- Trial name
- SONAR-ICE (NCT07353710)
- Testing
- ICE Image Acquisition
- Where
- 8 sites in Australia, Croatia and 6 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Paroxysmal AF, Atrial Arrhythmia
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in…
- Conditions
- Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- BLAST-OFF (NCT07181590)
- Testing
- Pulsed Field Ablation
- Where
- 22 sites in Austria, Belgium and 10 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
- Trial name
- TiPP (NCT04703166)
- Testing
- Samsung Galaxy Watch Active2
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Tulane University School of Medicine
Cardiac Pacemaker, Arrythmia
Aveir VR Coverage With Evidence Development Post-Approval Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- CED (NCT05336877)
- Testing
- Aveir VR Leadless Pacemaker System, Single-Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 8,744 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrhythmia
Aveir AR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
- Conditions
- Cardiac Pacemaker, Arrhythmia, Bradycardia
- Trial name
- ARRIVE (NCT06100770)
- Testing
- Aveir AR Leadless Pacemaker, Single-chamber atrial transvenous pacemaker
- Where
- United States
- Volunteers
- 586 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia
Evaluation of the DuoVT PFA System for Ventricular Tachycardia
This study is a prospective, non-randomized, single-arm, multicenter study to evaluate the safety and effectiveness of the DuoVT Pulsed Field Ablation (PFA) System.
- Trial name
- EXACT-VT (NCT07706712)
- Testing
- Ablation procedure with DuoVT PFA system
- Where
- 5 sites in Croatia, Czechia and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Arrhythmia, Ventricular
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
- Trial name
- MODULAR ATP (NCT04798768)
- Testing
- mCRM Therapy System
- Where
- 38 sites in United States, Austria and 7 more
- Volunteers
- 297 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Death, Cardiac Arrhythmias
Cardiovascular Pre-participation Screening in Children and Adolescents
Sports participation is strongly encouraged in children and adolescents, but intense training at early ages may reveal hidden heart conditions that increase the risk of sudden cardiac death.
- Trial name
- NCT07862504
- Testing
- Pre-participation clinical evaluation, Diagnostic Test: Resting 12-lead electrocardiogram, Diagnostic Test: Step test (Harvard step test)
- Where
- Brazil
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.
- Trial name
- PERFECT (NCT07343674)
- Where
- 12 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Portuguese Association of Interventional Cardiology
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death.
- Conditions
- Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia, Mantle Cell Lymphoma, Sudden Cardiac Death
- Trial name
- NCT05724121
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)