Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation : Part 2 (CONTRAST-CRYO 2)

Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation : Part 2 (CONTRAST-CRYO 2) - CONTRAST-CRYO 2 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052500

Enrollment

214

Registered

2023-12-01

Start date

2023-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal atrial fibrillation

Interventions

Ablation using the Arctic Front Cryoballoon (Medtronic) Ablation using the Polarx FIT Cryoballoon (Boston Scientific)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with initial ablation for paroxysmal atrial fibrillation At least 1 episode of paroxysmal AF have been documented within last 1 y of enrollment

Exclusion criteria

Exclusion criteria: Patients who underwent prior cardiac surgery Patients with AF secondary to a reversible cause Patients with contraindications to systemic anticoagulation Patients who are pregnant Patients who are not considered to be suitable candidates by the attending physician

Design outcomes

Primary

Measure	Time frame
Incidence of right phrenic nerve injury during the procedure	—

Secondary

Measure	Time frame
Freedom from any documented atrial tachyarrhythmias during 12 months follow-up after a single ablation procedure beyond 3 months of blanking period Freedom from any documented atrial fibrillation (AF) episodes Procedural duration, fluoroscopy time, dose of contrast Balloon temperature, proportion of veins with PV signals visible before cryoablation, and time-to-isolation of each pulmonary vein Total number of applications and total freeze duration of each pulmonary vein Esophageal temperature during freezing The incidence and location of non-PV arrhythmia foci Isolation area by cryoballoon ablation Freedom from repeat ablation procedure Freedom from direct current cardioversions for recurrent arrhythmias Prevalence of Peri-procedural complications Prevalence of pulmonary vein stenosis Prevalence of air embolism The impact of operators' experience Pulmonary vein isolation durability and the location of conduction resumption during second procedure Freedom from any documented atrial tachyarrhythmias after repeat ablation procedure	—

Measure

Time frame

Freedom from any documented atrial tachyarrhythmias during 12 months follow-up after a single ablation procedure beyond 3 months of blanking period Freedom from any documented atrial fibrillation (AF) episodes Procedural duration, fluoroscopy time, dose of contrast Balloon temperature, proportion of veins with PV signals visible before cryoablation, and time-to-isolation of each pulmonary vein Total number of applications and total freeze duration of each pulmonary vein Esophageal temperature during freezing The incidence and location of non-PV arrhythmia foci Isolation area by cryoballoon ablation Freedom from repeat ablation procedure Freedom from direct current cardioversions for recurrent arrhythmias Prevalence of Peri-procedural complications Prevalence of pulmonary vein stenosis Prevalence of air embolism The impact of operators' experience Pulmonary vein isolation durability and the location of conduction resumption during second procedure Freedom from any documented atrial tachyarrhythmias after repeat ablation procedure

—

Countries

Japan

Contacts

Public ContactShinsuke Miyazaki

Tokyo Medical and Dental University Department of cardiovascular medicine

mshicvm@tmd.ac.jp0358035205

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026