Clinical trials: Tachyarrhythmia
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
- Trial name
- NCT01639495
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Where
- 20 sites in United States
- Volunteers
- 148 people
- Sponsor
- Biosense Webster, Inc.
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure, Tachyarrhythmia
BIO|MASTER.Ilivia Family / Plexa
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
- Trial name
- NCT02774616
- Testing
- Ilivia ICD Family, Plexa ICD lead
- Where
- 25 sites in Australia, Austria and 8 more
- Volunteers
- 292 people
- Sponsor
- Biotronik SE & Co. KG
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
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Tachyarrhythmias, Syncope
Study of New Implantable Loop Recorder
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
- Trial name
- NCT00746564
- Testing
- SJM Confirm
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Diseases
Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti…
- Trial name
- MANDATE-AF (NCT04172883)
- Testing
- Treatment arm
- Where
- 11 sites in India
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
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
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
Sudden Cardiac Death, Bradycardia
REASSURE AV Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
- Trial name
- REASSURE (NCT01074034)
- Testing
- AV Therapy Assessment-B301 investigational device
- Where
- 36 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Scientific Corporation
COPD, Sepsis
Effect of Nebulized Bronchodilators on Heart Rate
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
- Conditions
- COPD, Sepsis, Shock
- Trial name
- NCT01151579
- Testing
- Levalbuterol, Albuterol
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Fahim Khorfan, MD
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure