Clinical trials: Tachyarrhythmia
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Heart Disease, Implantable Cardioverter Defibrillator (ICD)
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
This is a pragmatic, two-group, cluster randomized trial designed to compare strategies for the Anti Tachycardia Pacing (ATP)-setting in the ventricular tachyarrhythmias (VT) zone when implanting a new implantable cardioverter…
- Conditions
- Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders, Ventricular Tachyarrhythmias
- Trial name
- DAN-ATP (NCT07354347)
- Testing
- Burst, Ramp
- Where
- Denmark
- Volunteers
- 3,980 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Tachyarrhythmia
Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting.
- Trial name
- NCT06382207
- Testing
- Eko Duo electronic stethoscope, CORE 500 electronic stethoscope
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Virginia Commonwealth University
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 73 sites in United States, Austria and 5 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Tachyarrhythmia, Heart Failure
BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock_BC (Ilivia Neo, Intica Neo) implant and programmer software features.
- Trial name
- NCT07360158
- Testing
- CorSky ICD or CRT-D
- Where
- 7 sites in Austria, Czechia and 2 more
- Volunteers
- 151 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachyarrhythmia, Ventricular Arrythmia
Ventricular Catheter Ablation Study (VCAS)
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex…
- Conditions
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction
- Trial name
- VCAS (NCT06203262)
- Testing
- FieldForce™ Ablation System Ventricular Tachycardia, FieldForce™ Ablation System Premature Ventricular Contractions
- Where
- 2 sites in Czechia
- Volunteers
- 34 people
- Sponsor
- Field Medical
Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure
Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation
The goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential…
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure, Atrial Tachyarrhythmia Recurrence, Esophageal Thermal Injury
- Trial name
- VoS-PVI (NCT07354737)
- Testing
- Radiofrequency ablation catheter system
- Where
- South Korea
- Volunteers
- 130 people
- Sponsor
- Ajou University School of Medicine
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, Atrial Tachyarrhythmia
LEAF - Low Energy In Atrial Fibrillation
The purpose of the study is to demonstrate the efficiency on AT / AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications.
- Trial name
- NCT00157781
- Testing
- Medtronic AT500
- Volunteers
- 237 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Atrial Tachyarrhythmia
AdvisaTM IPG Clinical Evaluation Study
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
- Trial name
- NCT00839384
- Testing
- Advisa IPG
- Where
- Czechia
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Tachyarrhythmia
Full Automaticity and Remote Follow-up
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years.
- Trial name
- NCT01526629
- Where
- France
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Tachyarrhythmia
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by demonstrating clinical safety evaluating performance based…
- Trial name
- NCT05621187
- Testing
- Pamira ICD lead family
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 221 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmia, Atrial Fibrillation (AF)
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk…
- Conditions
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
- Trial name
- NCT04025710
- Testing
- BIOMONITOR III and BIOMONITOR IIIm
- Where
- 27 sites in Australia, Austria and 4 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Tachyarrhythmia
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance…
- Trial name
- NCT03891329
- Testing
- Acticor/Rivacor ICDs/CRT-Ds, Plexa S DX
- Where
- 13 sites in Austria, Germany and 5 more
- Volunteers
- 130 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachyarrhythmia, Sudden Cardiac Death
Domperidone and Risk of Serious Cardiac Events in Postpartum Women
The purpose of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following delivery.
- Conditions
- Ventricular Tachyarrhythmia, Sudden Cardiac Death, Lactation, Breast Feeding
- Trial name
- NCT04024865
- Testing
- Domperidone, No domperidone
- Where
- Canada
- Volunteers
- 184,929 people
- Sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
Tachyarrhythmia, Atrial Flutter
MCG for Localization of Tachyarrhythmia's Origin
This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and…
- Conditions
- Tachyarrhythmia, Atrial Flutter, Paroxysmal Supraventricular Tachycardia, Atrial Tachycardia
- Trial name
- NCT06327425
- Testing
- Magnetocardiography
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Qilu Hospital of Shandong University
Tachyarrhythmia, Atypical Atrial Flutter
Outcome of Induced Atypical Atrial Flutter
Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping…
- Conditions
- Tachyarrhythmia, Atypical Atrial Flutter, Induction of Arryhthmia, Clinical Outcome
- Trial name
- NCT06323499
- Testing
- Induction of atypical atrial flutter
- Where
- Germany
- Volunteers
- 76 people
- Sponsor
- University Hospital, Essen