Clinical trials: Paroxysmal AF
Atrial Fibrillation, Persistent Atrial Fibrillation
Feasibility Study of the FARAFLEX Mapping and PFA System
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or…
- Conditions
- Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
- Trial name
- ELEVATE-PF (NCT06510556)
- Testing
- FARAFLEX Ablation Treatment, ELEVATE-COR Sub-study
- Where
- 4 sites in Belgium, Croatia and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Paroxysmal AF
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and…
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent Atrial Fibrillation
- Trial name
- CLEAR (NCT07523620)
- Testing
- PVI Ablation, Left Atrial Appendage Occluder Implant
- Where
- 16 sites in Belgium, Czechia and 8 more
- Volunteers
- 240 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial…
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF), Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- ReDEFINE-AF (NCT07820930)
- Testing
- FARAFLEX Mapping and Pulsed Field Ablation System
- Volunteers
- 650 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Atrial Tachycardia
Conduction Breakthrough in the Coronary Sinus Post Endocardial Mitral Isthmus Ablation
The goal of this observational study is to learn more about how doctors can create a complete electrical block in the heart during catheter ablation procedures used to treat certain abnormal heart rhythms.
- Conditions
- Atrial Fibrillation (AF), Atrial Tachycardia, Paroxysmal AF, Persisent Atrial Fibrillation
- Trial name
- COSMIC (NCT07889440)
- Volunteers
- 50 people
- Sponsor
- Sebastien Knecht
Paroxysmal AF, Atrial Arrhythmia
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in…
- Conditions
- Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- BLAST-OFF (NCT07181590)
- Testing
- Pulsed Field Ablation
- Where
- 22 sites in Austria, Belgium and 10 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
- Trial name
- FOLLOW-AF (NCT07471308)
- Testing
- AF Recurrence RIsk Assessment post pulmonary vein isolation
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- CathVision ApS
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal AF
CENTAURI Post-Market Clinical Registry
The objective of this post-market clinical registry is to collect realworld clinical experience across multiple European centers regarding the safety and efficacy of the CENTAURI System
- Trial name
- CENTAURI Regis (NCT07874048)
- Testing
- CENTAURI System in conjunction with commercially available ablation catheters
- Volunteers
- 300 people
- Sponsor
- CardioFocus
Paroxysmal AF
FARAPULSE™ Pulsed Field Ablation System
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
- Trial name
- NCT06762717
- Testing
- FARAPULSE™ Pulsed Field Ablation system
- Where
- China
- Volunteers
- 501 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal AF
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF).
- Trial name
- VARIFY (NCT07236619)
- Testing
- Pulmonary vein isolation with the VariPulse catheter
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Erasmus Medical Center
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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 (AF), Atrial Fibrillation (Paroxysmal)
PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF
Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL).
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal), Persistent Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFPEF)
- Trial name
- PREACTIVE (NCT07324772)
- Testing
- progressive resistance training, combined aerobic + resistance training
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
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.
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF), Persistant Atrial Fibrillation, Paroxysmal AF
- Trial name
- COHERENT-AF (NCT06784466)
- Testing
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 360 people
- Sponsor
- Arga Medtech SA
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
Atrial Fibrillation (Paroxysmal), Paroxysmal AF
3-Dimensional Mapping System: The PULSTAR II Study
### Study Overview Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." Sponsor The study is sponsored by a company called Shanghai Shangyang…
- Conditions
- Atrial Fibrillation (Paroxysmal), Paroxysmal AF, Pulsed Field Ablation
- Trial name
- PAF (NCT07586176)
- Testing
- Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
Persistant Atrial Fibrillation, Paroxysmal AF
The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance.
- Trial name
- PF-MRI+ (NCT07499531)
- Testing
- Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
- Volunteers
- 39 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Atrial Fibrillation (Paroxysmal), Atrial Fibrillation (AF)
Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization
While radiofrequency and cryoballoon ablation have shown high rates of pulmonary vein reconnection in patients undergoing repeat electrophysiological evaluation for AF recurrence, early evaluations demonstrated a remarkably high…
- Conditions
- Atrial Fibrillation (Paroxysmal), Atrial Fibrillation (AF), Ablation of Atrial Fibrillation
- Trial name
- SWEET P-PFA (NCT06706518)
- Testing
- Single-shot ablation technologies
- Where
- Spain
- Volunteers
- 118 people
- Sponsor
- Daniel Rodríguez Muñoz
Paroxysmal AF, Treatment Decisions
Comparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration
Amiodarone is a highly effective drug for the treatment and prevention of arrhythmias. In the 1970s and 1980s, numerous experimental and clinical studies comprehensively examined the mechanisms of amiodarone's antiarrhythmic…
- Conditions
- Paroxysmal AF, Treatment Decisions, Therapeutic Drug Monitoring (TDM)
- Trial name
- AMIODETECT (NCT07487714)
- Testing
- Pharmacotherapy with amiodarone 200 mg per day, Treatment with Amiodarone at a dose 100 mg per day, Treatment with Amiodarone at a dose 400 mg per day
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences