Clinical trials: Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes.
- Trial name
- GANGLIA-AF (NCT02487654)
- Testing
- Pulmonary vein isolation, Ganglionated plexus ablation
- Where
- 3 sites in United Kingdom
- Volunteers
- 116 people
- Sponsor
- Imperial College London
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 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, 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
LSI (Lesion Index) Workflow Observational Study
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter…
- Trial name
- NCT03906461
- Testing
- Radiofrequency Ablation
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 143 people
- Sponsor
- Abbott Medical Devices
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
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Model Based Fast Anatomical Mapping
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
- Trial name
- MFAM (NCT03349476)
- Testing
- MFAM
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Vivek Reddy
Atrial Fibrillation Paroxysmal
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs. symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity and improve quality of life for AF patients.
- Trial name
- I-STOP-AFib (NCT03323099)
- Testing
- N-of-1, Data Tracking
- Where
- United States
- Volunteers
- 499 people
- Sponsor
- University of California, San Francisco
Paroxysmal Atrial Fibrillation
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard…
- Trial name
- NCT04356040
- Testing
- TactiFlex SE, TactiFlex SE - High Standard Power
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 355 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
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.
Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Tachycardia, Ventricular
- Trial name
- OPTIMUM (NCT04983797)
- Testing
- OPTRELL Mapping Catheter
- Where
- 3 sites in Belgium, Lithuania
- Volunteers
- 31 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Trial name
- Q-FFICIENCY (NCT03775512)
- Testing
- RF Ablation with QDOT Micro
- Where
- 22 sites in United States
- Volunteers
- 283 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.
- Trial name
- NCT03714178
- Testing
- FARAPULSE Endocardial Ablation System
- Where
- 2 sites in Czechia, France
- Volunteers
- 71 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
- Trial name
- PEFCATII (NCT04170608)
- Testing
- FARAPULSE Endocardial Multi Ablation System
- Where
- 2 sites in Croatia, Czechia
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
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 Atrial Fibrillation
TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic…
- Trial name
- TactiCathPAS (NCT02310100)
- Testing
- TactiCath Quartz treatment
- Where
- 20 sites in United States
- Volunteers
- 178 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and…
- Trial name
- LOCALIZE (NCT03232645)
- Testing
- Ablation procedure
- Where
- 6 sites in France, Germany and 2 more
- Volunteers
- 62 people
- Sponsor
- Boston Scientific Corporation