Clinical trials: Arrhythmias, Cardiac
Arrhythmia, Bradycardia
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices.
- Trial name
- NCT01076374
- Where
- 129 sites in United States, Austria and 10 more
- Volunteers
- 2,927 people
- Sponsor
- Medtronic
Atrial Fibrillation
Cardiac Resynchronization Therapy Efficacy Enhancements
The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the…
- Trial name
- CRTee (NCT02222818)
- Testing
- Conducted AF Response (CAFR), Conducted AF Response Plus (CAFRPlus)
- Where
- 19 sites in United States, Hungary and 5 more
- Volunteers
- 71 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Tachycardia
AutoMatic disPERsion Tagging Function Preliminary Evaluation
Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with…
- Conditions
- Atrial Fibrillation, Atrial Tachycardia, Atrial Arrhythmia
- Trial name
- AMPERE (NCT05362656)
- Testing
- VX1+ dispersion mapping
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Volta Medical
Atrial Arrhythmia, Atrial Fibrillation
VOLT CE Mark Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT06106594
- Testing
- Pulsed Field Ablation
- Where
- 11 sites in Australia, Austria and 5 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation.
- Trial name
- TOCCASTAR (NCT01278953)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Trial name
- TUNDRA-AF (NCT01259622)
- Testing
- saline, K201
- Where
- 17 sites in Denmark, Israel
- Volunteers
- 80 people
- Sponsor
- Sequel Pharmaceuticals, Inc
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Murmur, Heart, Rhythm; Abnormal
Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
The current study concerns Cardiags Trimod, a new non-invasive medical device for cardiac examinations. The evaluation of its effectiveness is done relative to specific standard devices.
- Trial name
- EVALTRIMOD (NCT05162599)
- Testing
- Diagnostic study, experimental evaluative cross-sectional study
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- CARDIAGS
Atrial Fibrillation
Patient Characteristics, Treatment Patterns And Incidence Of Events (Discontinuation, Persistence, Key Primary Clinical Outcomes) In NVAF Patients Initiating OAC Therapy In Colombia
The study aim to assess demographic and clinical characteristics , treatment patterns and as exploratory analysis will descriptively assess the time to clinical events of NVAF patients treated with oral anticoagulants (OACs) in…
- Trial name
- NCT04234698
- Where
- Colombia
- Volunteers
- 2,076 people
- Sponsor
- Pfizer
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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.
Arrhythmia, Syncope
Feasibility Study: Sleuth Monitoring System
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
- Trial name
- PULSE (NCT00719277)
- Testing
- Sleuth Implantable ECG Monitoring System
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- Transoma Medical
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Atrial Fibrillation
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal…
- Trial name
- AdmIRE (NCT05293639)
- Testing
- Pulse Field Ablation
- Where
- 30 sites in United States
- Volunteers
- 362 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
Atrial Fibrillation
AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after…
- Trial name
- NCT04538781
- Testing
- VASCADE MVP VVCS
- Where
- 4 sites in United States
- Volunteers
- 497 people
- Sponsor
- Cardiva Medical, Inc.
Heart Failure, Ventricular Arrythmia
ASCEND CSP IDE Study
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
- Trial name
- ASCEND CSP IDE (NCT06830746)
- Testing
- LBBAP Implant with a CSP ICD Lead
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 414 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.
- Trial name
- NCT00126061
- Testing
- Tedisamil sesquifumarate
- Where
- 26 sites in United States, Czechia and 3 more
- Sponsor
- Solvay Pharmaceuticals
Atrial Fibrillation
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
Atrial Fibrillation (AF), Stoke
Abbott Medical - VERITAS Study
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are…
- Trial name
- NCT06707688
- Testing
- Amulet™ 2 Left Atrial Appendage (LAA) Occluder
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Abbott Medical Devices
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