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
Persistent Atrial Fibrillation
Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding…
- Trial name
- NO PERS-AF (NCT03008811)
- Testing
- Pulmonary vein isolation with cryoballoon catheter., Pulmonary vein isolation with radiofrequency ablation.
- Where
- 3 sites in Norway
- Volunteers
- 101 people
- Sponsor
- Haukeland University Hospital
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
Atrial Fibrillation
Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor
The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein…
- Trial name
- RACE-AF (NCT03805555)
- Testing
- Radiofrequency ablation, Cryoballoon ablation
- Where
- Denmark
- Volunteers
- 105 people
- Sponsor
- University Hospital, Gentofte, Copenhagen
Valvular Atrial Fibrillation
Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation.
- Trial name
- NCT03920891
- Testing
- Cryoballoon Pulmonary Vein isolation, Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
- Where
- South Korea
- Volunteers
- 154 people
- Sponsor
- Yonsei University
Arrhythmia
FREEZE Cohort Study
Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.
- Trial name
- NCT01360008
- Where
- 37 sites in United States, Austria and 4 more
- Volunteers
- 4,071 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Paroxysmal Atrial Fibrillation
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.
- Trial name
- NCT01611701
- Testing
- cryoballoon ablation, Radiofrequency ablation
- Where
- 2 sites in United States, Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Paroxysmal Atrial Fibrillation
SINGLE SHOT CHAMPION
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming…
- Trial name
- NCT05534581
- Testing
- PVI using the Arctic Front Cryoballoon (Medtronic), PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)
- Where
- 2 sites in Switzerland
- Volunteers
- 210 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Atrial Fibrillation, CryoAblation
Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation
The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.
- Conditions
- Atrial Fibrillation, CryoAblation, Pulmonary Vein Isolation
- Trial name
- WACACF vs Cryo (NCT03564925)
- Testing
- Wide area circumferential ablation, Cryoballoon ablation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
Atrial Fibrillation (AF)
Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF).
- Trial name
- CRAAFT-HF (NCT06505798)
- Testing
- Catheter Ablation
- Where
- 24 sites in Canada, United Kingdom
- Volunteers
- 1,200 people
- Sponsor
- University College, London
Paroxysmal Atrial Fibrillation
Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with…
- Trial name
- TRACE-AF (NCT03268707)
- Testing
- Telemetric smartphone application, Conventional follow up
- Where
- 2 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Atrial Fibrillation
Study Comparing Pulmonary Vein Isolation With the Cryoballoon, Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF)
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation, or both together in the treatment of paroxysmal…
- Trial name
- Cryo Vs RFA (NCT01038115)
- Testing
- Atrial fibrillation ablation
- Where
- United Kingdom
- Volunteers
- 237 people
- Sponsor
- Barts & The London NHS Trust
Cardiovascular Diseases
CAB Versus Medical Therapy in Patients With AF and HF With Different EF Categories
This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.
- Trial name
- NCT05364866
- Testing
- Antiarrhythmic drug Therapy, cryoballoon ablation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Affiliated Hospital of Nantong University
Atrial Fibrillation
Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon…
- Trial name
- SD-CRYO-AF (NCT03003975)
- Testing
- PVI by single cryoballoon application guided by Achieve Mapping Catheter, PVI by 2 routine cryoballoon applications
- Where
- Sweden
- Volunteers
- 140 people
- Sponsor
- Uppsala University Hospital
Atrial Fibrillation, Atrial Fibrillation Paroxysmal
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
Rationale: Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with…
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
- Trial name
- ISOLATION (NCT04342312)
- Testing
- Pulmonary vein isolation
- Where
- 2 sites in Netherlands
- Volunteers
- 500 people
- Sponsor
- Maastricht University
Atrial Fibrillation
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).
- Trial name
- NCT06324188
- Testing
- Early atrial fibrillation ablation, Usual Care
- Where
- 7 sites in Australia, Canada and 5 more
- Volunteers
- 2,312 people
- Sponsor
- Atrial Fibrillation Network
Atrial Fibrillation, Persistent
First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation
The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon…
- Trial name
- NCT05939076
- Testing
- Pulmonary vein isolation, dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™
- Where
- 6 sites in Hungary, Slovakia and 2 more
- Volunteers
- 220 people
- Sponsor
- Region Örebro County
Atrial Fibrillation, Heart Failure
Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation
Rationale: Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality.
- Conditions
- Atrial Fibrillation, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic
- Trial name
- RACE-8-HF (NCT04342832)
- Testing
- Cryoballoon ablation
- Where
- 2 sites in Netherlands
- Volunteers
- 64 people
- Sponsor
- Maastricht University
Atrial Fibrillation and Flutter, Atrial Fibrillation
HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials.
- Conditions
- Atrial Fibrillation and Flutter, Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- Trial name
- HIPAF (NCT04855890)
- Testing
- Ablation
- Where
- Germany
- Volunteers
- 170 people
- Sponsor
- Universitätsklinikum Köln