Clinical trials: Cryoballoon Ablation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation.
- Trial name
- ABLATE (NCT01877486)
- Testing
- Ablation
- Where
- United States
- Sponsor
- University of Rochester
Atrial Fibrillation, Persistent Atrial Fibrillation
Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonary veins (PVs) at the back of…
- Trial name
- LAUDABLE (NCT04111731)
- Testing
- Cryoballoon pulmonary vein isolation, Radiofrequency pulmonary vein isolation, Repeat electrophysiological study
- Where
- 3 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
Atrial Fibrillation
Cryoballoon Atrial Fibrillation Ablation Registry
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label
- Trial name
- NCT03040037
- Where
- Russia
- Volunteers
- 1,100 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Atrial Fibrillation
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).
- Trial name
- NCT06183879
- Testing
- cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon), cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
- Where
- 2 sites in Croatia
- Volunteers
- 150 people
- Sponsor
- University of Zagreb
Persistent Atrial Fibrillation
Effects of Different Surgical Methods for Persistent Atrial Fibrillation Combined With the Application of Statin Drugs on Left Atrial Function
A total of 164 patients with persistent atrial fibrillation, who are planned to undergo treatment with cryoballoon ablation, will be randomly allocated into two groups.
- Trial name
- NCT03700307
- Testing
- Cryoballoon ablation
- Where
- China
- Volunteers
- 164 people
- Sponsor
- The Second Hospital of Hebei Medical University
Atrial Fibrillation
Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population
Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in…
- Trial name
- CLACBAC (NCT04185142)
- Testing
- cryoballoon ablation combining with left atrial appendage closure
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai 10th People's Hospital
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
Barrett's Esophagus, Esophageal Squamous Dysplasia
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer.
- Conditions
- Barrett's Esophagus, Esophageal Squamous Dysplasia, Esophageal Cancer
- Trial name
- ColdPlay2 (NCT02534233)
- Testing
- CryoBalloon
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Johns Hopkins University
Atrial Fibrillation
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality.
- Trial name
- CRYO-MAP (NCT01448265)
- Testing
- Cryoballoon ablation.
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Heidelberg University
Atrial Fibrillation
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation
The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF…
- Trial name
- era-cryo (NCT05492760)
- Testing
- cryoballoon ablation
- Volunteers
- 600 people
- Sponsor
- Shanghai 10th People's Hospital
Persistent Atrial Fibrillation
Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial…
- Trial name
- PIVoTAL-IDE (NCT04505163)
- Testing
- Standard Cryoballoon Pulmonary Vein Isolation (PVI), Cryoballoon PVI + Posterior Wall Isolation
- Where
- 11 sites in United States
- Volunteers
- 153 people
- Sponsor
- Dignity Health Medical Foundation
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
Atrial Fibrillation
PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)
This study is designed as a randomized, controlled, prospective, non-inferiority clinical trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated) will be compared to the standard ablation…
- Trial name
- FreezeAF (NCT00774566)
- Testing
- PV-Isolation RF, PV-Isolation Cryo
- Where
- Germany
- Volunteers
- 322 people
- Sponsor
- Staedtisches Klinikum Karlsruhe
Atrial Fibrillation
Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation
This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard…
- Trial name
- CRYO-LATS (NCT03199703)
- Testing
- Baylis transseptal system group, Standard conventional transseptal group
- Where
- 6 sites in Canada
- Volunteers
- 135 people
- Sponsor
- Jason Andrade
Atrial Fibrillation
Effect of Left Atrial Ablation on Left Atrial Appendage Emptying Flow Velocity
Consecutive patients with paroxysmal AFib scheduled to undergo pulmonary vein isolation either with radiofrequency (RF) or cryoballoon will be included.
- Trial name
- ABLAA-FV (NCT02801175)
- Testing
- Pulmonary vein isolation
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- National and Kapodistrian University of Athens
Atrial Fibrillation
Rotational Angiography in Cryoballoon Ablation
There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation.
- Trial name
- NCT04293757
- Testing
- Rotational angiography
- Where
- Croatia
- Volunteers
- 128 people
- Sponsor
- University of Zagreb
Persistent Atrial Fibrillation
Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation
This clinical study is being conducted to compare two different treatment methods for persistent atrial fibrillation (AF), a common heart rhythm disorder.
- Trial name
- PEACE (NCT07064616)
- Testing
- Catheter ablation using pulsed field ablation, Catheter ablation using cryoballoon ablation
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Kitasato University
Atrial Fibrillation (AF)
Antral Lesions Characterization of a New Cryoballoon Ablation System in Terms of Local Impedance Drop
Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction.
- Trial name
- CryoLID (NCT05410379)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Maria Cecilia Hospital
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
Atrial Fibrillation, Catheter Ablation
Registry Evaluating AF Ablation Techniques
The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the…
- Trial name
- PRIME-AF (NCT03695484)
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 212 people
- Sponsor
- Erasmus Medical Center