Atrial Fibrillation
Conditions
Brief 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.
Detailed description
With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation. Secondary objectives are also defined as: * Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.). * To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. * Description of the complications related to the procedure. * To evaluate the use of healthcare resources which this cryoablation procedure entails.
Interventions
PROCEDUREBalloon cryoablation
pulmonary vein cryoablation for atrial fibrillation
Sponsors
Medtronic
Medtronic Cardiac Ablation Solutions
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. | 12 months | Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Acute Efficacy of the Procedure: | 24-48h | Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. |
| Number of Adverse Events Related to the Procedure | Up 30 days post procedure | The outcome measure is the number of Adverse Events Related to the Procedure |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Atrial Fibrillation Patients with paroxysmal and persistent atrial fibrillation who meet criteria to receive a cryoablation procedure. | 1,742 |
| Total | 1,742 |
Baseline characteristics
| Characteristic | Patients With Atrial Fibrillation |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 |
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Diabetes Mellitus | 9.1 percentage of patients |
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Dyslipidemia | 34.7 percentage of patients |
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Hypertension | 46.3 percentage of patients |
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Ischemia Stroke/TIA | 5.3 percentage of patients |
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Smokers | 13.3 percentage of patients |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Spain | 1742 participants |
| Sex: Female, Male Female | 543 Participants |
| Sex: Female, Male Male | 1199 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,742 |
| other Total, other adverse events | 262 / 1,742 |
| serious Total, serious adverse events | 34 / 1,742 |
Outcome results
Primary
The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation.
Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Atrial Fibrillation | 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 |
Secondary
Number of Adverse Events Related to the Procedure
The outcome measure is the number of Adverse Events Related to the Procedure
Time frame: Up 30 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Atrial Fibrillation | Number of Adverse Events Related to the Procedure | 120 adverse events |
Secondary
The Acute Efficacy of the Procedure:
Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
Time frame: 24-48h
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Atrial Fibrillation | The Acute Efficacy of the Procedure: | 1726 participants |