Clinical trials: Arrhythmias
Atrial Fibrillation
Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain
Depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice
- Trial name
- HEROIC (NCT02262676)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Spain
- Volunteers
- 2,251 people
- Sponsor
- Bayer
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
Left Ventricular Dysfunction, Ventricular Dysfunction
Low Ejection Fraction in Single Lead ECG
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left…
- Conditions
- Left Ventricular Dysfunction, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT05010655
- Testing
- Use of Eko DUO Electronic Stethoscope
- Where
- 2 sites in United States
- Volunteers
- 1,935 people, healthy volunteers welcome
- Sponsor
- Eko Devices, Inc.
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
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
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Cardiac Arrhythmias
ViewFlex X ICE First-in-Human Study
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data…
- Trial name
- ViewFlex X FIH (NCT06772493)
- Testing
- ViewFlex X ICE System
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
Study of JK07 in Patients With Chronic Heart Failure
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
- Trial name
- RENEU-HF (NCT06369298)
- Testing
- JK07
- Where
- 62 sites in United States, Canada and 2 more
- Volunteers
- 282 people
- Sponsor
- Salubris Biotherapeutics Inc
Atrial Fibrillation
Initial Experience With Spatial Resynchronization Therapy in Patients With Atrial Fibrillation
Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.
- Trial name
- SR-TheAF (NCT05461612)
- Testing
- Spatial Resynchronization Therapy delivered by the MAX-SRS, external recording and stimulation device
- Where
- Georgia
- Volunteers
- 30 people
- Sponsor
- Maxwell Biomedical
Cardiac Arrhythmias
Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
- Trial name
- E20PC (NCT02326519)
- Testing
- Intracardiac electrode catheter
- Where
- 2 sites in Austria, France
- Volunteers
- 31 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Syncope
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM)…
- Conditions
- Atrial Fibrillation, Syncope, Cryptogenic Stroke
- Trial name
- LUX-Dx PERFORM (NCT04732728)
- Where
- 24 sites in United States
- Volunteers
- 727 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation (PFA) by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and TRUPULSE generator) when used for isolation of the…
- Trial name
- ZephIRE (NCT06495216)
- Testing
- Pulsed Field Ablation by a Balloon Catheter with the TRUPULSE Generator
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
- Trial name
- RIVA-DM (NCT04509193)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- United States
- Volunteers
- 116,049 people
- Sponsor
- Bayer
Atrial Fibrillation
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention…
- Trial name
- SAFARI (NCT01805531)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- France
- Volunteers
- 411 people
- Sponsor
- Bayer
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial…
- Trial name
- FARADIGM (NCT07575269)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation (PFA) System
- Where
- 13 sites in United States, Belgium and 2 more
- Volunteers
- 571 people
- Sponsor
- Boston Scientific Corporation
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.
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
Persistent Atrial Fibrillation
The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF…
- Trial name
- CS1543 (NCT05272852)
- Testing
- FARAPULSE™ Pulsed Field Ablation System Plus
- Where
- 2 sites in Czechia
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Tachycardia
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)".
- Trial name
- ASSUREMRI (NCT03012568)
- Testing
- SJM Implantable cardiac devices
- Where
- 3 sites in Australia, India
- Volunteers
- 119 people
- Sponsor
- Abbott Medical Devices
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