Clinical trials: Atrial Fibrillation Paroxysmal
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
A Dose-range Finding Study of MAA868 in Patients With Atrial Fibrillation
This study is a multicenter, randomized, subject and Investigator-blinded, placebo-controlled, parallel-group, multiple ascending dose-ranging study to evaluate the safety, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT04213807
- Testing
- MAA868 Cohort 1, MAA868 Cohort 2, MAA868 Cohort 3
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Anthos Therapeutics, Inc.
Paroxysmal Atrial Fibrillation
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal…
- Trial name
- ADVENT LTO (NCT06526546)
- Where
- 25 sites in United States
- Volunteers
- 364 people
- Sponsor
- Boston Scientific Corporation
Heart Diseases, Arrhythmia
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial…
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- NCT01385202
- Testing
- THERMOCOOL® SMARTTOUCH™ Catheter
- Volunteers
- 172 people
- Sponsor
- Biosense Webster, Inc.
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
Paroxysmal Atrial Fibrillation (PAF)
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens.
- Trial name
- INSTANT (NCT03539302)
- Testing
- Flecainide Acetate
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 176 people
- Sponsor
- InCarda Therapeutics, Inc.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT05773170
- Testing
- Refralon
- Where
- 33 sites in Russia
- Volunteers
- 1,147 people
- Sponsor
- R-Pharm
Atrial Fibrillation
A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial…
- Trial name
- PulseSmart (NCT06272981)
- Testing
- Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
- Where
- 7 sites in Australia, Canada
- Volunteers
- 136 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation
The NEXT PULSE study is a pre-market, prospective, multi-center, non-randomized, interventional clinical study. Adult subjects with symptomatic paroxysmal or persistent AF who provided consent will be enrolled and treated with…
- Trial name
- NEXT PULSE (NCT07575828)
- Testing
- PulseSelect Pulse Field Ablation (PFA) System
- Volunteers
- 320 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
- Trial name
- DIAMOND-AF (NCT03334630)
- Testing
- DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
- Where
- 23 sites in United States, Canada and 3 more
- Volunteers
- 482 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory…
- Trial name
- NEwTON AF (NCT04580914)
- Testing
- Treatment with IntellaNav StablePoint Ablation Catheter
- Where
- 47 sites in United States, Austria and 11 more
- Volunteers
- 321 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Treatment of PAF With the Synaptic System
Enrolled subjects will be treated with the Synaptic Cryoablation System. Treatment will include cryoablation of the pulmonary veins to achieve PVI.
- Trial name
- Sensation (NCT05905835)
- Testing
- Synaptic Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 128 people
- Sponsor
- Synaptic Medical Corporation
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Feasibility Study on the FARAVIEW Technology
The purpose of this study is to gather data regarding the utilization of the FARAVIEW™ feature of the RHYTHMIA HDx Mapping System when used in conjunction with the FARAWAVE NAV Pulsed Field Ablation catheter in subjects…
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NAVIGATE PF (NCT06175234)
- Testing
- Ablation Treatment
- Where
- 3 sites in Czechia, Ireland and 1 more
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Paroxysmal Arrhythmia
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
- Trial name
- SFAF (NCT01585961)
- Testing
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Where
- 45 sites in United States
- Volunteers
- 511 people
- Sponsor
- Biosense Webster, Inc.
Arrhythmia
Qubic Stim Cardiac Stimulator in China
106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese…
- Trial name
- NCT04390841
- Testing
- Cardiac Stimulator
- Where
- 3 sites in China
- Volunteers
- 106 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
- Trial name
- PULSAR (NCT05462145)
- Testing
- Globe Pulsed Field System
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 549 people
- Sponsor
- Kardium Inc.
Paroxysmal Atrial Fibrillation
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients.
- Trial name
- SUPIR (NCT01645917)
- Testing
- Arctic Front Advance Cardiac CryoAblation system
- Where
- Czechia
- Volunteers
- 21 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure