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Register on cryo-ablation in local hospitals

Register on cryo-ablation in local hospitals

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016504
Enrollment
1000
Registered
2019-01-28
Start date
2018-12-14
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

Interventions

Group 1: Prospective, consecutive register to define effectivity and complication data in pulmonary vein isolation using the cryoballoon ablation technique

Sponsors

Bonifatius Hospital Lingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Consecutive patients undergoing pulmonary vein isolation for symptomatic atrial fibriallation at the study sites.

Exclusion criteria

Exclusion criteria: No exclusion criteria apart from missing patient informed consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a security endpoint consisting of a combination of potentially important complication during pulmonary vein isolation: Death, insult, pericardial effusion, osophageal - atrial fistula, phrenic nerve palsy, vessel access complication. The total number of the before mentioned complications with be counted and related to the total number of procedures.

Secondary

MeasureTime frame
The secondary endpoint is an effectivity endpoint as number of documented isolation of all 4 pulmonary veins directly after the pulmonary vein isolation

Countries

Germany

Contacts

Public ContactRainer Hoffmann

Bonifatius Hospital Lingen

rainer.hoffmann@hospital-lingen.de05919106251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026