Clinical trials: Atrial Fibrillation (Paroxysmal)
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
Paroxysmal Atrial Fibrillation
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.
- Trial name
- NCT01900678
- Testing
- VytronUS Ablation System
- Where
- Czechia
- Volunteers
- 7 people
- Sponsor
- VytronUS, Inc.
Paroxysmal Atrial Fibrillation
Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the…
- Trial name
- FACT-AF (NCT01185613)
- Testing
- Therapy™ Cool Flex Ablation Catheter
- Where
- 6 sites in Australia, France and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF…
- Trial name
- NCT05872776
- Testing
- Neuromodulation with RR2 device
- Where
- 2 sites in Israel
- Volunteers
- 50 people
- Sponsor
- Ziv HealthCare Ltd.
Atrial Fibrillation, Hypertension
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a…
- Trial name
- Symplicity AF (NCT02064764)
- Testing
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Arctic Front Advance™ Cardiac Cryoablation System
- Where
- 10 sites in United States, Germany
- Volunteers
- 102 people
- Sponsor
- Medtronic Vascular
Atrial Fibrillation (AF)
Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac…
- Trial name
- NCT07811934
- Testing
- Investigational Cardiac Pulsed Field Ablation (PFA) System, Conventional Radiofrequency (RF) Catheter Ablation System
- Volunteers
- 284 people
- Sponsor
- Shanghai Shineyo Medical Co., Ltd.
Paroxysmal Atrial Fibrillation
Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.
The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- QDOT-FAST (NCT03459196)
- Testing
- THERMOCOOL SMARTTOUCH SF-5D Catheter
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 54 people
- Sponsor
- Biosense Webster, Inc.
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.
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in…
- Trial name
- inspIRE (NCT04524364)
- Testing
- Pulsed Field Ablation (PFA) Therapy
- Where
- 13 sites in Austria, Belgium and 6 more
- Volunteers
- 272 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)
- Trial name
- POLAR SMART (NCT05282823)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Japan, South Korea
- Volunteers
- 295 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
ACT DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation
The primary objective of this study is to establish the safety and performance effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).
- Trial name
- TRAC-AF (NCT02821351)
- Testing
- Radio frequency (RF) Cardiac ablation
- Where
- 4 sites in Czechia, France
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal Atrial Fibrillation
Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).
- Trial name
- VISUALISE AF (NCT03852420)
- Testing
- LUMINIZE RF Balloon Catheter
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
ADVENT Post Approval Study
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
- Trial name
- ADVENTPAS (NCT06431815)
- Testing
- FARAPULSE™ Pulsed Field Ablation System
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 228 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
TactiCath® Prospective Effectiveness Pilot Study
EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.
- Trial name
- EFFICAS II (NCT02131337)
- Testing
- Electrophysiology study
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 45 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
FIRE AND ICE Re-Ablations (Retrospective Data Collection)
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
- Trial name
- Re-Do (NCT03314753)
- Testing
- No interventions - retrospective data collection
- Where
- 13 sites in Czechia, France and 4 more
- Volunteers
- 89 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation Paroxysmal
FOCALFLEX (CE Mark) Study
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ Pulse Field Ablation (PFA) Generator, and EnSite™ X EP System with EnSite™ Pulsed…
- Trial name
- NCT06271967
- Testing
- TactiFlex™ Ablation Catheter Sensor Enabled™
- Where
- 24 sites in Australia, Austria and 9 more
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
Atrial Fibrillation
Safety and Efficacy of CryoCor™ Cryoablation for PAF
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
- Trial name
- NCT00231296
- Testing
- Cardiac CryoCor Cryoablation System, Medical management
- Where
- 24 sites in United States
- Volunteers
- 174 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices