Clinical trials: Arrhythmia
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Cardiovascular Diseases, Arrhythmias, Cardiac
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac…
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- Trial name
- ICE-ACCESS (NCT07788040)
- Testing
- Intracardiac Echocardiography Catheter
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
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
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
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
Arrhythmias, Cardiac, Atrial Fibrillation
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode…
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Heart Diseases
- Trial name
- NCT06358391
- Testing
- TS-RF Transseptal Needle, BRK Transseptal Needle
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Starmed
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Ventricular Arrhythmia, Tachycardia
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.
- Trial name
- NCT06048731
- Testing
- Defibrillation using EV-ICD
- Where
- 130 sites in United States, Austria and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic
Cardiac Arrhythmia
Smart Textile ECG Monitoring
This research is a clinical evaluation of the Skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ECG) signals.
- Trial name
- NCT06870175
- Testing
- Electronic-Textile-based Electrocardiographic Monitoring
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- Myant Medical Corp.
Atrial Fibrillation
A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with…
- Trial name
- NCT07217067
- Testing
- PKN605
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 165 people
- Sponsor
- Novartis Pharmaceuticals