Clinical trials: Paroxysmal Arrhythmia
Atrial Fibrillation, Atrial Fibrillation New Onset
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation
To provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal atrial fibrillation, without the requirement that the…
- Trial name
- STOP AF First (NCT03118518)
- Testing
- Cryoablation, Antiarrhythmic drug
- Where
- 24 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation
Efficacy and Safety Study on Agilis NxT Introducer in AF Patients
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using…
- Trial name
- AGILIS (NCT00469638)
- Testing
- Left atrial catheter ablation guided by introducer using Agilis sheeth, Left atrial catheter ablation guided by introducer using Non-steerable sheeth
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact…
- Conditions
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Trial name
- WAVE-MAP AF (NCT03882021)
- Testing
- A specific electrophysiology mapping protocol is applicable with the GRID catheter.
- Where
- 15 sites in Austria, Czechia and 7 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)
The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in…
- Trial name
- LOCALIZE CF (NCT04740801)
- Testing
- Ablation procedure
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
POLARx Post Approval Study (POLARx PAS)
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein…
- Trial name
- NCT06170606
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Oral Anticoagulation Therapy Pilot Study
The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.
- Trial name
- OAT (NCT01959425)
- Testing
- Off OAT Group (Test), On OAT Group (Control)
- Volunteers
- 80 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
GENESIS Feasibility Study of the BARD Over-the-Wire Mesh Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The Genesis Feasibility Study will collect clinical information on the use of the Bard Over-the-Wire Mesh Ablation System to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the…
- Trial name
- GENESIS (NCT01430949)
- Testing
- Catheter Ablation of Paroxysmal Atrial Fibrillation
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- C. R. Bard
Paroxysmal Atrial Fibrillation
Antiarrhythmic and Symptomatic Effect of ISIS CRP Rx Targeting CRP in Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate whether treatment with ISIS CRP Rx can reduce AF (Atrial Fibrillation) burden (percentage of time spent in AF) in subjects with paroxysmal AF
- Trial name
- ASET (NCT01710852)
- Testing
- ISIS CRP Rx
- Where
- United Kingdom
- Volunteers
- 7 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
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.
Atrial Fibrillation, Afib
Clinical Performance of the AFGen1 Device Over a 7-day Period
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib.
- Conditions
- Atrial Fibrillation, Afib, Irregular Heart Beat, Arrhythmias, Cardiac
- Trial name
- NCT05295056
- Testing
- AFGen1 Device Wear Test, AFGen 1 Device Single Use
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- TriVirum, Inc.
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
Paroxysmal Atrial Fibrillation
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- IMPACT (NCT03700372)
- Testing
- IOWA Approach Cardiac Ablation System
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Boston Scientific Corporation
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
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 Atrial Fibrillation
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
- Trial name
- FROZEN-AF (NCT04133168)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent
MultiPulse Therapy (MPT) for AF
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent, Atrial Fibrillation
- Trial name
- NCT04206917
- Testing
- Multi Pulse Therapy
- Where
- 6 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Cardialen, Inc.
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada.
- Trial name
- Stop-AF (NCT00523978)
- Testing
- Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
- Where
- 26 sites in United States, Canada
- Volunteers
- 245 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
DIAMOND AF Post-Approval Study
The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial
- Trial name
- DAF PAS (NCT05230524)
- Testing
- DiamondTemp™ Ablation System
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 84 people
- Sponsor
- Medtronic Cardiac Ablation Solutions