Clinical trials: Arrythmia, Cardiac
ATRIAL FIBRILLATION, Syncope
BioMonitor Master Study
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation.
- Trial name
- BioMonitor (NCT01725568)
- Testing
- BioMonitor
- Where
- Germany
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Paroxysmal Atrial Fibrillation
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
- Trial name
- POLAR SMART (NCT05282823)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Japan, South Korea
- Volunteers
- 295 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter…
- Trial name
- TACTIC AF (NCT01650298)
- Testing
- Drug (Direct thrombin or Factor Xa inhibitor)
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Abbott Medical Devices
Sick Sinus Syndrome
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace…
- Trial name
- VIPERS (NCT01528657)
- Testing
- Ventricular Pace Suppression (Vps), Intrinsic rhythm support (IRSplus)
- Where
- 20 sites in Italy
- Volunteers
- 230 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Feasibility Study on the FARAVIEW Technology
The purpose of this study is to gather data regarding the utilization of the FARAVIEW™ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects…
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NAVIGATE PF (NCT06175234)
- Testing
- Ablation Treatment
- Where
- 3 sites in Czechia, Ireland and 1 more
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF)
Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial…
- Trial name
- COMBINATION 2P (NCT07036965)
- Testing
- CardiPulse, FaraPulse
- Where
- China
- Volunteers
- 292 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Arrhythmia
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed…
- Trial name
- NCT00187239
- Testing
- Autointrinsic Conduction Search Algorithm
- Where
- United States
- Volunteers
- 157 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
- Trial name
- NCT00189319
- Testing
- Flecainide controlled release
- Where
- France
- Volunteers
- 200 people
- Sponsor
- MEDA Pharma GmbH & Co. KG
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Atrial Fibrillation
CONTAK RENEWAL 3 AVT
The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias
- Trial name
- NCT00158977
- Testing
- CONTAK RENEWAL 3 AVT
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrythmia, Lead
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
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) and PASSIVE…
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- FRIENDS (NCT03766919)
- Testing
- Implant of the INVICTA lead
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the…
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
- Trial name
- ICE-AFIB (NCT03732794)
- Testing
- AtriCure CryoICE & AtriClip LAA Exclusion
- Where
- 15 sites in United States
- Volunteers
- 150 people
- Sponsor
- AtriCure, Inc.
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Arrhythmia, Quality of Life
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies.
- Trial name
- NCT00325221
- Testing
- HM on, HM Off
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 148 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using…
- Trial name
- NCT03122028
- Testing
- LAA closure system
- Volunteers
- 61 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
- 97 sites in United States, Austria and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Atrial Fibrillation
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Atrial Fibrillation
Tailored Treatment of Permanent Atrial Fibrillation
The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
- Trial name
- TTOP-AF (NCT00514735)
- Testing
- Medtronic Cardiac Ablation System, Class I or III Antiarrhythmic Medications
- Where
- 24 sites in United States, Netherlands
- Volunteers
- 210 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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