N/A
Completed N=1,742
Spanish Registry of Cryoballoon Ablation
Source: ClinicalTrials.gov NCT02785991 ↗Enrolled (actual)
1,742
Serious AEs
2.0%
Results posted
Mar 2022
Primary outcomePrimary: The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. — 79 percentage of patients freedom from AF
Summary
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. |
79 | — |
| SECONDARY The Acute Efficacy of the Procedure: |
1726 | — |
| SECONDARY Number of Adverse Events Related to the Procedure |
120 | — |
Eligibility Criteria
Inclusion Criteria
- Signature of the Data Release Form
- Subjects ≥ 18 years old
- Subjects who meet the indication for the Cryoballoon Ablation procedure.
Exclusion Criteria
- Subjects with a life expectancy of less than 12 months.
- Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.).
- Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study.
- Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
Data sourced from ClinicalTrials.gov (NCT02785991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.