Clinical trials: Cryoballoon Ablation
Esophageal Cancer
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
- Trial name
- NCT02729727
- Testing
- CryoBalloon Ablation System
- Where
- Netherlands
- Volunteers
- 3 people
- Sponsor
- Pentax Medical
Barrett's Esophagus
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
This is a feasibility study without a primary study hypothesis or statistical comparison.
- Trial name
- NCT01633411
- Testing
- Focal Cryoballoon Ablation System - 6 seconds, Focal Cryoballoon Ablation System - 8 seconds, CryoBalloon Focal Ablation System - 10 seconds
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 39 people
- Sponsor
- Pentax Medical
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Barrett Esophagus
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's…
- Trial name
- NCT03311451
- Testing
- C2 CryoBalloon 180° Ablation System
- Where
- 6 sites in Netherlands
- Volunteers
- 62 people
- Sponsor
- Merit Medical Systems, Inc.
Barrett Esophagus
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
- Trial name
- ColdPlayIII (NCT02514525)
- Testing
- CryoBalloon Ablation System
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Pentax Medical
Atrium; Fibrillation, Ablation
Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer.
- Trial name
- PROOF (NCT04293198)
- Testing
- KODEX-EPD System, Fluoroscopy with contrast dye
- Where
- 2 sites in United States, Belgium
- Volunteers
- 63 people
- Sponsor
- EPD Solutions, A Philips Company
Barrett Esophagus
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
- Trial name
- NCT03097666
- Testing
- C2 CRYOBALLOON SWIPE ABLATION SYSTEM
- Where
- 3 sites in Netherlands
- Volunteers
- 24 people
- Sponsor
- Pentax Medical
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Esophageal Squamous Cell Dysplasia
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia
To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.
- Trial name
- NCT02605759
- Testing
- CryoBalloon Focal Ablation System
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Pentax Medical
Atrial Fibrillation
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)
The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early…
- Trial name
- NCT02213731
- Testing
- Holter monitoring
- Where
- 14 sites in France, Germany and 1 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation, Atrial Arrhythmia
FIRE AND ICE II Trial Pilot
The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI)…
- Trial name
- NCT03706677
- Testing
- Cryoballoon (Arctic Front Advance Cryoballoon), Radiofrequency Catheter (ThermoCool Smarttouch)
- Where
- 5 sites in France, Germany
- Volunteers
- 69 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Esophageal Cancer
Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study
- Trial name
- NCT02729753
- Testing
- CryoBalloon™ Full Ablation System, CryoBalloon™ Swipe Ablation System
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pentax Medical
Barrett's Esophagus
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
- Trial name
- NCT02249975
- Testing
- C2 CryoBalloon Focal Ablation System
- Where
- 2 sites in Netherlands
- Volunteers
- 50 people
- Sponsor
- Pentax Medical