Clinical trials: Ventricular Arrythmia
Atrial Fibrillation, Heart Failure
Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent…
- Trial name
- CASTLE-AF (NCT00643188)
- Testing
- Radiofrequency ablation, Conventional treatment
- Where
- 32 sites in Australia, Austria and 6 more
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardiac Defibrillator Continued Access Study
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
- Trial name
- EV ICD CA (NCT05049720)
- Testing
- Defibrillation using the Extravascular ICD
- Sponsor
- Medtronic
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Master Study (Safety and Efficacy Study)
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01790841
- Testing
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death, Ventricular Fibrillation
LifeVest Post-CABG Registry
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease…
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction
- Trial name
- NCT01448005
- Testing
- wearable defibrillator (LifeVest)
- Where
- 5 sites in United States
- Volunteers
- 69 people
- Sponsor
- Zoll Medical Corporation
Heart Failure, Ventricular Arrhythmias
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)
This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.
- Trial name
- BENEFIT (NCT00996086)
- Testing
- CRT device implant
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Ischemic Ventricular Tachycardia
Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.
- Trial name
- EZCF-125 (NCT01032317)
- Testing
- Radiofrequency Catheter Ablation
- Where
- Czechia
- Volunteers
- 22 people
- Sponsor
- Biosense Webster, Inc.
Tachycardia, Ventricular
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial…
- Trial name
- SMS (NCT00170287)
- Testing
- ICD Ablation plus VT-ablation, ICD Therapy
- Where
- 7 sites in Denmark, Germany
- Volunteers
- 116 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Ventricular Arrhythmia, Ventricular Tachycardia
Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study
The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- SECURE EV (NCT05352776)
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 18 people
- Sponsor
- AtaCor Medical, Inc.
Atrioventricular Conduction Block
Micra Atrial Tracking Using a Ventricular Accelerometer Study
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.
- Trial name
- MARVEL (NCT03157297)
- Testing
- MARVEL algorithm
- Where
- 13 sites in United States, Austria and 7 more
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Arrhythmia
Novel Cardiac Signal Processing System
This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems.
- Trial name
- NCT04112433
- Testing
- PURE EP 2
- Where
- 3 sites in United States
- Volunteers
- 104 people
- Sponsor
- BioSig Technologies, Inc.
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.
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 Arrythmia, Lead
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- APOLLO (NCT04590144)
- Testing
- INVICTA lead
- Where
- 45 sites in Austria, France and 6 more
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Atrial Fibrillation
MODULA Modul 7 VRR
This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial…
- Trial name
- NCT00180414
- Testing
- CRT devices with ventricular rate regulation [VRR] (CE labeled)
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- Boston Scientific Corporation
Death, Sudden, Cardiac, Ventricular Fibrillation
Medtronic Genetic Arrhythmia Markers for Early Detection (GAME Study)
To generate a list of potential genetic markers that correlate with an increased risk of life-threatening arrhythmias. To evaluate ECG-based risk markers such as heart rate variability and T-wave Alternans for their association…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- GAME (NCT00664807)
- Where
- United States
- Volunteers
- 1,023 people
- Sponsor
- Medtronic Corporate Technologies and New Ventures
Tachycardia, Ventricular
PAtient NOtifier Feature for Reduction of Anxiety
This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety
- Trial name
- Panoramic (NCT00559559)
- Testing
- ICD implant + Patient Notifier turned OFF, ICD Implant + Patient Notifier turned ON
- Where
- Switzerland
- Volunteers
- 362 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
Hypertension, Atrial Fibrillation
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial
In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.
- Trial name
- NCT00256152
- Testing
- AF Suppression Pacing Algorithm
- Where
- Canada
- Volunteers
- 2,580 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiac Arrhythmia
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality.
- Conditions
- Heart Failure, Cardiac Arrhythmia, Left Ventricular Dysfunction
- Trial name
- BIO|Adapt (NCT04774523)
- Testing
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization, Echocardiography
- Where
- Spain
- Volunteers
- 198 people
- Sponsor
- Biotronik SE & Co. KG