Freezing the Pulmonary Veins Using a Single Shot Compliant Balloon-Technique: the PolarX™ - Cryo-Balloon

Freezing the Pulmonary Veins Using a Single Shot Compliant Balloon-Technique: the PolarX™ - Cryo-Balloon - FreezeCompliant

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021075

Enrollment

240

Registered

2021-01-25

Start date

2021-01-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I48.0

Interventions

Group 1: pulmonary vein isolation with PolarX cryo balloon ablation

analysis of procedural parameters (procedure time, fluoro time, isolation ratio, a.o.)

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients who received a cryo balloon ablation due to atrial fibrillation

Exclusion criteria

Exclusion criteria: ? unwillingness to sign the informed consent ? Pregnancy ? estimated lifetime < 1 year

Design outcomes

Secondary

Measure	Time frame
1. Successful isolation of all pulmonary veins with all applicable technologies 2. Successful isolation of all pulmonary veins with the cryo balloon with accounting for the anatomy 3. Successful isolation of all pulmonary veins with one cryo application 4. Total procedure time 5. Total fluoro time and dosage 6. Incidence of any complications	—

Primary

Measure	Time frame
Successful isolation of all pulmonary veins with the cryo balloon	—

Countries

Croatia, Germany

Contacts

Public ContactArmin Luik

Städtisches Klinikum Karlsruhe Medizinische Klinik IV

luik@klinikum-karlsruhe.de0721-9742901

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026