Clinical trials: Ventricular Arrythmia
Heart Failure, Tachycardia, Ventricular
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
- Trial name
- NCT02235545
- Testing
- St. Jude Medical Optisure Lead
- Where
- 60 sites in United States, Belgium and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Abbott Medical Devices
Ventricular Fibrillation, Ventricular Flutter
SAFEty of Two Strategies of ICD Management at Implantation
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable…
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Trial name
- SAFE-ICD (NCT00661037)
- Testing
- Implantable defibrillator
- Where
- Italy
- Volunteers
- 2,120 people
- Sponsor
- Boston Scientific Corporation
Ventricular Fibrillation, Ventricular Tachycardia
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output
- Trial name
- UNTOUCHED (NCT02433379)
- Testing
- EMBLEM S-ICD System
- Where
- 110 sites in United States, Belgium and 11 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
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
Atrioventricular Block, Ventricular Dysfunction
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of…
- Trial name
- NCT00187278
- Testing
- Biventricular Pacing, RV Pacing
- Where
- Germany
- Volunteers
- 1,833 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
A Multi-centre Study Comparing the Effects of AZD2927 and Placebo on the Electrical Activity in the Heart in Patients
Medical Products Agency
- Trial name
- NCT01396226
- Testing
- AZD2927
- Where
- 5 sites in Norway, Sweden
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Ventricular Tachycardia
Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study
This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.
- Trial name
- NCT01401608
- Testing
- RF Ablation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Stereotaxis
Bradycardia
ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with…
- Trial name
- ENHANCE (NCT01559311)
- Testing
- CRT-P OFF, CRT-P ON, DDDR
- Where
- 7 sites in Australia, China and 3 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Bradycardia, Chronotropic Incompetence
Common Sensing and Right Ventricular Automatic Capture (COGNATE)
This study will collect data on features for future pacemakers via an external non-implantable system.
- Trial name
- COGNATE (NCT01030705)
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias
The purpose of this investigation is to determine the prevalence of device-recorded ST segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD) therapies (ATP or Shock) and to define their temporal…
- Trial name
- inSighT (NCT01685047)
- Where
- Germany
- Volunteers
- 481 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices
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
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
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.
Tachycardia, Ventricular Arrhythmias
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
- Trial name
- NCT02772380
- Testing
- Defibrillation following induction of VT/VF
- Where
- 36 sites in United States, Australia and 10 more
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Conduction Defect
Subcostal Temporary Extravascular Pacing V Study
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System…
- Trial name
- STEP V (NCT05633394)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 29 people
- Sponsor
- AtaCor Medical, Inc.
Arrhythmia
Atorvastatin For The Reduction Of Ventricular Arrhythmias
To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular…
- Trial name
- CLARIDI (NCT00457340)
- Testing
- Atorvastatin 80mg
- Where
- 10 sites in Belgium, Greece
- Volunteers
- 220 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia, Ventricular Fibrillation
OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
This study evaluates the date of the first appropriate and/or inappropriate therapy in patients implanted with a Guidant PRIZM or VITALITY defibrillator and is evaluating eventual predictive risk factors for…
- Trial name
- NCT00180375
- Testing
- Prizm, Vitality, Renewal
- Where
- 33 sites in France
- Volunteers
- 636 people
- Sponsor
- Boston Scientific Corporation