Clinical trials: Arrhythmia Atrial
Atrial Fibrillation
Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.
- Trial name
- RESTART (NCT05477147)
- Testing
- Catheter Ablation
- Where
- 19 sites in United States, Belgium and 2 more
- Volunteers
- 96 people
- Sponsor
- Volta Medical
Atrial Fibrillation
Propafenone in the Treatment of Atrial Fibrillation
This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed…
- Trial name
- NCT03674658
- Testing
- Propafenone
- Where
- Taiwan
- Volunteers
- 71 people
- Sponsor
- TSH Biopharm Corporation Limited
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF).
- Trial name
- NCT04680026
- Testing
- HBI-3000
- Where
- 14 sites in United States, Bosnia and Herzegovina and 3 more
- Volunteers
- 150 people
- Sponsor
- HUYABIO International, LLC.
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.
- Trial name
- HESTIA (NCT01135017)
- Testing
- Dronedarone
- Where
- 92 sites in United States
- Volunteers
- 112 people
- Sponsor
- Sanofi
Atrial Fibrillation (AF), Atrial Premature Complexes
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia
- Trial name
- Kardi Ai (NCT07018648)
- Testing
- Medical device
- Where
- 2 sites in Czechia
- Volunteers
- 115 people
- Sponsor
- KARDI AI Technologies s.r.o.
Paroxysmal Atrial Fibrillation
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, Inc.
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Medtronic Terminate AF Study
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
- Trial name
- NCT03546374
- Testing
- Surgical Ablation, Cardioblate and Cryoflex hand held devices
- Where
- 15 sites in United States
- Volunteers
- 160 people
- Sponsor
- Medtronic Cardiac Surgery
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
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
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation.
- Trial name
- OLAAC (NCT02105584)
- Testing
- Implantation of LAA closure device
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 78 people
- Sponsor
- Occlutech International AB
Atrial Fibrillation, Arrhythmias, Cardiac
Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart…
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
- Trial name
- NCT03335800
- Testing
- Apple Heart Study App
- Where
- United States
- Volunteers
- 419,927 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Atrial Fibrillation
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- SmartfIRE (NCT05752487)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 9 sites in Austria, Belgium and 2 more
- Volunteers
- 149 people
- Sponsor
- Biosense Webster, Inc.
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Current or Recent History of Atrial Fibrillation
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who…
- Trial name
- GENETIC-AF (NCT01970501)
- Testing
- bucindolol hydrochloride, metoprolol succinate
- Where
- 97 sites in United States, Canada and 4 more
- Volunteers
- 267 people
- Sponsor
- ARCA Biopharma, Inc.
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Venous Thromboembolism
Edoxaban Management in Diagnostic and Therapeutic Procedures
Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without…
- Trial name
- EMIT-AF/VTE (NCT02950168)
- Testing
- Edoxaban
- Volunteers
- 1,197 people
- Sponsor
- Daiichi Sankyo
Paroxysmal Atrial Fibrillation
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low…
- Trial name
- VITAL (NCT03513029)
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- VytronUS, Inc.
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