Clinical trials: Cardiac Conduction Defect
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Tachycardia, Ventricular
S-ICD® System IDE Clinical Study
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
- Trial name
- NCT01064076
- Testing
- S-ICD System
- Where
- 33 sites in United States, Netherlands and 2 more
- Volunteers
- 330 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Tachycardia
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)".
- Trial name
- ASSUREMRI (NCT03012568)
- Testing
- SJM Implantable cardiac devices
- Where
- 3 sites in Australia, India
- Volunteers
- 119 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia, Premature Ventricular Contraction
RMN Versus Manual Epicardial Retrospective PMCF
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or…
- Trial name
- EPINAV (NCT04171479)
- Testing
- Epicardial mapping and/or ablation
- Where
- 3 sites in Czechia, Netherlands
- Volunteers
- 40 people
- Sponsor
- Stereotaxis
Tachycardia, Ventricular
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory…
- Trial name
- RADIATE-VT (NCT05765175)
- Testing
- Varian Cardiac Radioablation (CRA), Catheter Ablation (CA)
- Where
- 11 sites in United States
- Volunteers
- 380 people
- Sponsor
- Varian, a Siemens Healthineers Company
Ventricular Tachycardia, Arrythmia
Rook Epicardial Access Device Study
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device.
- Trial name
- NCT03427333
- Testing
- The Rook® Epicardial Access Kit
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Talon Surgical
Ventricular Tachycardia, Ventricular Fibrillation
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation Lead
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
- Trial name
- NCT00180297
- Testing
- Endotak Reliance G
- Where
- 18 sites in France
- Volunteers
- 215 people
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation, Tachycardia, Supraventricular
Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter.
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia
- Trial name
- PRE-ALERT (NCT05357716)
- Testing
- HeartWatch, Event Recorder, Holter Monitor
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- HelpWear Inc.
Sudden Cardiac Death, Sudden Cardiac Arrest
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident…
- Trial name
- WED-HED (NCT02481206)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 31 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zoll Medical Corporation
Atrial Fibrillation, Tachycardia
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months.
- Conditions
- Atrial Fibrillation, Tachycardia, ICD Therapy, Thromboembolic Events
- Trial name
- MATRIX (NCT01774357)
- Where
- Germany
- Volunteers
- 2,054 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia
China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or…
- Trial name
- CN_MRI_ICD (NCT03828357)
- Testing
- Study MRI scan
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
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
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
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Premature Ventricular Contraction, Ventricular Tachycardia
VIVO™ Accuracy Study
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
- Trial name
- NCT03340142
- Testing
- VIVO™
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Catheter Precision. Inc.
Ventricular Tachycardia, Ventricular Fibrillation
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation.
- Trial name
- NCT03853369
- Testing
- Nifekalant hydrochloride
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
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
Ventricular Fibrillation, Ventricular Tachycardia
SD01 Registry (SD01 ICD Lead)
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- SD01 Registry (NCT02014675)
- Testing
- SD01 ICD lead
- Where
- 10 sites in Germany
- Volunteers
- 280 people
- Sponsor
- Biotronik SE & Co. KG