Clinical trials: Afib
Atrial Fibrillation
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic…
- Trial name
- OMNY-AF (NCT06455098)
- Testing
- OMNYPULSE™ Catheter with the TRUPULSE Generator
- Where
- 41 sites in United States, Australia
- Volunteers
- 354 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this non-interventional study to gain insight into…
- Trial name
- NCT02951039
- Testing
- Edoxaban
- Where
- 47 sites in South Korea, Taiwan
- Volunteers
- 3,008 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Paroxysmal Atrial Fibrillation
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal.
- Trial name
- NCT03624881
- Testing
- Catheter ablation with EPU
- Where
- 41 sites in United States
- Volunteers
- 333 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment.
- Trial name
- HARMONY (NCT01522651)
- Testing
- Ranolazine, Dronedarone
- Where
- 50 sites in United States, Germany and 5 more
- Volunteers
- 134 people
- Sponsor
- Gilead Sciences
Atrial Fibrillation
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
This study is designed to evaluate the safety of DTI-0009 in patients with atrial fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.
- Trial name
- NCT00040001
- Testing
- DTI-0009
- Where
- United States
- Sponsor
- Aderis Pharmaceuticals
Atrial Fibrillation (AF), Paroxysmal AF
Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF).
- Trial name
- Harbor-AF (NCT07792239)
- Testing
- Budiodarone 200 mg BID, Budiodarone 400 mg BID, Budiodarone 600 mg BID
- Where
- 4 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Xyra, LLC
Atrial Fibrillation
Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.
- Trial name
- X-PRESS (NCT02876718)
- Testing
- Rivaroxaban (Xarelto, BAY 59-7939)
- Where
- Taiwan
- Volunteers
- 253 people
- Sponsor
- Bayer
Atrial Fibrillation
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
- Trial name
- NCT01896297
- Testing
- Pradaxa, dabigatran etexilate
- Where
- 26 sites in United States
- Volunteers
- 63 people
- Sponsor
- Boehringer Ingelheim
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Optimal Sensing in Atrial Tachyarrhythmia's Study
The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of…
- Trial name
- OSAT (NCT01074749)
- Testing
- Accent Pacemaker
- Where
- Netherlands
- Volunteers
- 111 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
ArcticLine Feasibility Study
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
- Trial name
- NCT03604263
- Testing
- ArcticLine Cardiac Cryoablation Catheter
- Where
- 4 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
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
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
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).
- Trial name
- NCT00973323
- Testing
- Xarelto (Rivaroxaban, BAY59-7939), Warfarin
- Where
- 10 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Bayer
Stroke
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial…
- Trial name
- ASAP-TOO (NCT02928497)
- Testing
- WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control)
- Where
- 92 sites in United States, Belgium and 7 more
- Volunteers
- 481 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial…
- Trial name
- NCT00352560
- Testing
- Irbesartan
- Where
- 3 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Bristol-Myers Squibb