Clinical trials: Cryoballoon Ablation
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.
Atrial Fibrillation, Persistent
Comparison Between Extended Cryoablation, Standard Cryoablation, and Radiofrequency Ablation
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
- Trial name
- EXCAPE-AF (NCT07034378)
- Testing
- Radiofrequency ablation, Extended cryoballoon ablation, Standard cryoballoon ablation
- Where
- 3 sites in South Korea
- Volunteers
- 288 people
- Sponsor
- Asan Medical Center
Symptomatic Paroxysmal Atrial Fibrillation
Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus…
- Trial name
- MACPAF (NCT01061931)
- Testing
- Arctic Front® catheter vs. HD Mesh Ablator® catheter
- Where
- Germany
- Volunteers
- 108 people
- Sponsor
- Charite University, Berlin, Germany
Paroxysmal Atrial Fibrillation
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation, and it can reduce the procedure time compared to conventional radiofrequency (RF) catheter ablation.
- Trial name
- NCT03920917
- Testing
- Cryoballoon Pulmonary Vein isolation, Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
- Where
- South Korea
- Volunteers
- 330 people
- Sponsor
- Yonsei University
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
Atrial Flutter, Atrial Fibrillation
Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Background: Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it…
- Trial name
- PAF CRIOBLAF (NCT01521988)
- Testing
- Atrial flutter ablation, Atrial flutter ablation and pulmonary vein isolation
- Where
- 15 sites in France
- Volunteers
- 76 people
- Sponsor
- University Hospital, Rouen
Atrial Fibrillation, Persistent, Arrhythmias, Cardiac
Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation
This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.
- Trial name
- Cryo-InitialAF (NCT04942834)
- Testing
- Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone, cryoballoon ablation
- Where
- 17 sites in China
- Volunteers
- 320 people
- Sponsor
- Ruijin Hospital
Atrial Flutter Typical
Cryoballoon Ablation as First Line Treatment of Atrial Flutter
Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that recurrences of flutter and incidence of…
- Trial name
- CRAFT (NCT03401099)
- Testing
- Radiofrequency ablation of CTI, Cryoballoon PVI
- Where
- 10 sites in Switzerland, United Kingdom
- Volunteers
- 113 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
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
Gastric Cancer, Cryoballoon Ablation
A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores…
- Trial name
- NCT06957977
- Testing
- Endoscopic Cryoballoon Ablation Treatment, PD1 Inhibitor
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Zhongguang Luo, MD
Atrial Fibrillation, Heart Failure
Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure
The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart…
- Conditions
- Atrial Fibrillation, Heart Failure, Cryoballon Ablation
- Trial name
- POLAR-HF (NCT04461691)
- Testing
- Cryoballoon Pulmonary Vein Isolation
- Where
- Germany
- Volunteers
- 1,420 people
- Sponsor
- St. Josefs-Hospital Wiesbaden GmbH
Atrial Fibrillation
Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use.
- Trial name
- CAFE (NCT06701383)
- Testing
- Cryoablation
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Medisch Spectrum Twente
Atrial Fibrillation
A Time-to-effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation
This study aims to validate a new dosage of cryotherapy based on time to effect in pulmonary vein ablation procedures in patients with paroxysmal atrial fibrillation.
- Trial name
- plusONE (NCT02789358)
- Testing
- Conventional cryotherapy dosage, Experimental cryotherapy dosage, Arctic Front Advance ST Cryoenergy Balloon Catheter
- Where
- Spain
- Volunteers
- 140 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
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
Atrial Fibrillation Recurrence After Cryoballoon Ablation
The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System.
- Trial name
- NCT01772030
- Testing
- Use of the Achieve catheter followed by ICE-guided mapping catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Pittsburgh
Atrial Fibrillation Paroxysmal
Zero-fluoroscopic Cryoballoon Ablation
This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT05711589
- Testing
- CBA was performed under intracardiac echocardiography guidance without fluoroscopy, cryoablation (CBA) was performed under fluoroscopic guidance
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Pusan National University Hospital
Dysphagia, Esophageal Cancer
Focal Cryoballoon Ablation for Malignant Dysphagia
Rationale: Dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment.
- Conditions
- Dysphagia, Esophageal Cancer, Cryotherapy
- Trial name
- DYS-CBAS (NCT06618742)
- Testing
- Cryotherapy
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Laura Boer
Paroxysmal Atrial Fibrillation
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
- Trial name
- C-frost (NCT01920295)
- Testing
- Cryoballoon ablation
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Yuksek Ihtisas Hospital
Persistent Atrial Fibrillation
Cryoballoon Pulmonary Vein Isolation vs. Cryoballoon Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Persistent Atrial Fibrillation (CRARAL Trial)
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation. However, it is not certain that cryoablation is effective and safe in patients with persistent atrial…
- Trial name
- NCT03682887
- Testing
- Cryoballoon PV isolation group, Cryoballoon PV isolation with Additional RA linear ablation group
- Where
- South Korea
- Volunteers
- 195 people
- Sponsor
- Yonsei University
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