Clinical trials: Ventricular Arrythmia
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
Ventricular Arrhythmias
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).
- Trial name
- NCT00273195
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 41 sites in United States, Austria and 5 more
- Volunteers
- 500 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrythmia, Ventricular Fibrillation
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls.
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ALARION EV (NCT07324031)
- Testing
- Atala™ lead and EV-ICD Pulse Generator
- Where
- 35 sites in United States, Netherlands
- Volunteers
- 280 people
- Sponsor
- AtaCor Medical, Inc.
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachycardia, Ventricular Fibrillation
Leader - Evaluation of Endotak Reliance
The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.
- Trial name
- NCT00180349
- Testing
- Endotak Reliance
- Where
- 25 sites in France
- Volunteers
- 904 people
- Sponsor
- Boston Scientific Corporation
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
Ventricular Fibrillation
Acute Feasibility Investigation of a New S-ICD Electrode
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
- Trial name
- ASE (NCT03802110)
- Testing
- commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
- Where
- 4 sites in Netherlands
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
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 Tachyarrhythmia
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF testing regarding the efficacy of the first ICD shock for…
- Trial name
- NCT01282918
- Testing
- ICD implantation w/o DF test, ICD implantation with DF test
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 1,077 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF
The aim of this multi-center research study is to evaluate the performance (primary purpose) and safety of a new algorithm aimed at controlling ventricular rate (VR) during rapidly conducted atrial fibrillation (AF) by delivering…
- Trial name
- AVNS (NCT01095952)
- Testing
- AVNS ON
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 45 people
- Sponsor
- Medtronic BRC
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- FEATHER (NCT07116525)
- Testing
- Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 90 people
- Sponsor
- Biosense Webster, Inc.
Tachycardia, Ventricular
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System.
- Trial name
- EFFORTLESS (NCT01085435)
- Testing
- S-ICD System
- Where
- 44 sites in Czechia, Denmark and 8 more
- Volunteers
- 994 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD)
PREPARE - Primary Prevention Parameters Evaluation
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter…
- Conditions
- Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
- Trial name
- NCT00279279
- Testing
- Implanted Device
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
- 12 sites in United States
- Volunteers
- 380 people
- Sponsor
- Varian, a Siemens Healthineers Company
Ventricular Fibrillation, Ventricular Tachycardia
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause.
- Trial name
- REFORM (NCT00401466)
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 155 people
- Sponsor
- Biotronik SE & Co. KG
Conduction Defect
Subcostal Temporary Extracardiac Pacing Study
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events.
- Trial name
- STEP (NCT04096365)
- Testing
- Subcostal Temporary Extracardiac Pacing Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.