Clinical trials: Catheter Ablation
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Hypertension
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
- Trial name
- EnligHTN-I (NCT01438229)
- Testing
- St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
- Where
- 4 sites in Australia, Greece
- Volunteers
- 47 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation…
- Trial name
- Staged DEEP (NCT01661205)
- Testing
- Ablation procedure staged catheter ablation
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest.
- Trial name
- Tailored-AF (NCT04702451)
- Testing
- Dispersion ablation + PVI, VX1, PVI
- Where
- 26 sites in United States, Belgium and 3 more
- Volunteers
- 377 people
- Sponsor
- Volta Medical
Atrial Flutter
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in patients with atrial flutter.
- Trial name
- NCT00326001
- Testing
- Gold tip catheter, Platinum-iridium tip catheter
- Where
- 28 sites in Czechia, Germany and 1 more
- Volunteers
- 463 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Flutter
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter.
- Trial name
- BLOCk-CTI (NCT01253200)
- Testing
- Blazer® Open-Irrigated Ablation Catheter, Control Catheter
- Where
- 26 sites in United States
- Volunteers
- 302 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System.
- Trial name
- SPHERE Per-AF (NCT05120193)
- Testing
- Mapping and Ablation
- Where
- 23 sites in United States, Czechia and 1 more
- Volunteers
- 477 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Atrial Fibrillation
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized…
- Trial name
- ERACE (NCT01520532)
- Testing
- Magnetic Resonance Imaging (MRI)
- Where
- 7 sites in Belgium, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation
AF Substrate Mapping and Guided Ablation
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to…
- Trial name
- NCT02571218
- Testing
- Substrate+mCPVA, mCPVA
- Where
- Italy
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
- Trial name
- SHINE (NCT03437733)
- Testing
- Radiofrequency Ablation
- Where
- 5 sites in Czechia, Italy and 1 more
- Volunteers
- 98 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Atrial Flutter
An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias
- Trial name
- NCT04210622
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- Lithuania
- Volunteers
- 16 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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.
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the…
- Trial name
- NCT03650556
- Testing
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
- Where
- 22 sites in United States, Australia
- Volunteers
- 224 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined…
- Trial name
- DEEP (NCT01246466)
- Testing
- Hybrid: AtriCure Bipolar System & EP ablation procedure
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating…
- Trial name
- CACAF-2 (NCT00227344)
- Testing
- RF ablation, Antiarrhythmic drugs
- Volunteers
- 129 people
- Sponsor
- Biosense Webster EMEA
Atrial Flutter
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
- Trial name
- NCT00318565
- Testing
- RF energy delivery for treatment of Typical Atrial flutter
- Where
- 23 sites in United States
- Volunteers
- 291 people
- Sponsor
- Biosense Webster, Inc.
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 people
- Sponsor
- Biosense Webster, 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.