Clinical trials: Atrial Arrhythmia
Atrial Fibrillation (AF), Paroxysmal AF
PulseMagic™ TrueForce™ PAF NMPA Study
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
- Trial name
- PFATrueForce (NCT07720557)
- Testing
- PFA Ablation catheter
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Arrhythmia, Atrial Fibrillation
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF).
- Trial name
- NCT04685317
- Testing
- Sentinel® Cerebral Protection System, Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Malini Madhavan
Atrial Fibrillation, Atrial Flutter
HeartBeam ECG Registry
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Bradycardia, Tachycardia
- Trial name
- NCT07501299
- Testing
- Electrocardiogram (ECG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- HeartBeam, Inc.
Atrial Fibrillation (AF), Chronic Lymphocytic Leukemia
Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor Therapy
This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI).
- Conditions
- Atrial Fibrillation (AF), Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma
- Trial name
- NCT07711327
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Tina Baykaner
Atrial Fibrillation, Heart Failure
RAFT - Pace &Ablate
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Trial name
- RAFT-P&A RCT (NCT06299514)
- Testing
- Pace and Ablate, Medication
- Where
- 12 sites in Canada
- Volunteers
- 600 people
- Sponsor
- Habib Khan
Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent
Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).
- Conditions
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrium; Fibrillation, Atrial Arrhythmia
- Trial name
- CLIP-AF (NCT06165510)
- Testing
- Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device., Standard Endocardial Catheter Ablation
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Barts & The London NHS Trust
Atrial Fibrillation (AF), Cardiac Arrhythmias
Comparison of 7-Day ECG Patches
This prospective, randomized, multi-arm study evaluates the usability and performance of commercially available CE-certified 7-day ECG patches in an outpatient setting.
- Trial name
- NCT07564349
- Testing
- Smartcardia 7L Patch, ECG247, HeartX Recorder
- Where
- Austria
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Atrial Fibrillation, Arrhythmia
First-time Ablation of Atrial Fibrillation Registry
Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050.
- Trial name
- DIPE (NCT06381245)
- Testing
- PPG-based remote heart rhythm/rate monitoring, ECG-based remote heart rhythm/rate monitoring, Transthoracic and transesophageal echocardiography examination
- Where
- Poland
- Volunteers
- 340 people
- Sponsor
- Medical University of Warsaw
Atrial Fibrillation, Atrial Arrhythmia
VOLta Medical AI-software in REal-World During AF Ablation
This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping…
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac
- Trial name
- VOLTAIRE-AF (NCT07621055)
- Testing
- Cardiac mapping
- Where
- 3 sites in France
- Volunteers
- 150 people
- Sponsor
- Volta Medical
Subclinical Atrial Fibrillation, Cardiac Arrhythmias
The Clinical Outcomes and Therapeutic Effects in Patients With Cardiac Implantable Electronic Device-detected Subclinical and Clinical Atrial Fibrillation.
Atrial high-rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of progression to clinical atrial fibrillation (AF), stroke, heart failure, and mortality.
- Trial name
- AHRE (NCT07649109)
- Testing
- Early Rhythm Control Strategy, Usual Care
- Where
- Taiwan
- Volunteers
- 450 people
- Sponsor
- National Taiwan University Hospital
Atrial Fibrillation, Atrial Arrhythmia
Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall…
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia, Atrial Flutter, Atrial Tachycardia
- Trial name
- NCT05014802
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Tulane University
Chronic Kidney Disease With and Without Hemodialysis
Patterns of Cardiac Arrhythmia in Patients With Chronic Kidney Disease
Cardiovascular diseases remain the primary leading cause of death in patients on maintenance hemodialysis accounting for nearly 41% of deaths.
- Trial name
- Arrhythmia (NCT07640919)
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Sohag University
Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents
Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia…
- Conditions
- Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF)
- Trial name
- CATCH (NCT06164808)
- Testing
- HeartWatch
- Where
- Canada
- Volunteers
- 300 people
- Sponsor
- HelpWear Inc.
Cardiac Arrhythmia, Atrial Fibrillation
Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia.
- Trial name
- WEAR-TECH ECG (NCT05298553)
- Testing
- Group A, Group B
- Where
- 3 sites in United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Oxford University Hospitals NHS Trust
Atrial Fibrillation (AF), Atrial Arrhythmia
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and…
- Conditions
- Atrial Fibrillation (AF), Atrial Arrhythmia, Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation
- Trial name
- FlexPulse IDE (NCT06676072)
- Testing
- PFA Ablation catheter
- Where
- 32 sites in United States, Austria and 2 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Atrial Fibrillation, Ventricular Fibrillation
Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter
Monophasic action potential (MAP) recording plays an important role in a more direct view of human myocardial electrophysiology under both physiological and pathological conditions.
- Conditions
- Atrial Fibrillation, Ventricular Fibrillation, Junctional Tachycardia
- Trial name
- EvaMAP (NCT01254474)
- Testing
- Cardiac chambers mapping with MAP 4
- Where
- France
- Volunteers
- 42 people
- Sponsor
- University Hospital, Bordeaux
Ablation of Arrhythmia's
Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems
This prospective, randomized, parallel-group interventional study will compare cerebral microembolization during pulmonary vein isolation between different pulsed field ablation systems in patients with paroxysmal or persistent…
- Trial name
- MICROPFA (NCT07610018)
- Testing
- Pulsed field ablation using PulseSelect system, Pulsed field ablation using Varipulse system, Pulsed field ablation using Farapulse system
- Where
- 2 sites in Croatia
- Volunteers
- 100 people
- Sponsor
- Ivan Zeljkovic
Atrial Fibrillation (Prevention of Stroke), Arrythmia, Cardiac
Pharmacy-based Opportunistic Atrial Fibrillation Screening Integrated With Emergency Services (NUMAPLUS-FA)
This study evaluates the feasibility and fidelity of an opportunistic atrial fibrillation (AF) screening programme conducted in 38 community pharmacies in Seville (Spain), using the Kardias® 6-lead portable ECG device…
- Conditions
- Atrial Fibrillation (Prevention of Stroke), Arrythmia, Cardiac, Mass Screening, Pharmacies
- Trial name
- Numaplus_FA (NCT07598903)
- Testing
- Integrated pharmacy-based AF screening circuit
- Where
- Spain
- Volunteers
- 380 people
- Sponsor
- Centro de Emergencias Sanitarias 061 Andalucía
Atrial Arrhythmias
The Field PULSE Study
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF…
- Trial name
- NCT06452589
- Testing
- FieldForce Ablation System
- Where
- Czechia
- Volunteers
- 35 people
- Sponsor
- Field Medical