Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P12-16 | Other Identifier | METC Twente |
Not provided
Not provided
Safety point reached, subjects in the 3D CT overlay group received sugnificantly less contrast.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fluorscopy | Active Comparator | Cryoablation using a balloon with standard fluoroscopy |
|
| 3D CT overlay | Experimental | Cryoablation using a balloon with 3D CT overlay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Pulmonary vein isolation using cryoablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time | To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay | Procedure time |
| radiation exposure | To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay | Procedure time |
| Contrast | To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay | Amount of contrast during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. | one year |
Not provided
Inclusion Criteria:
- All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jurren van Opstal, MD, PhD | Medisch Spectrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Overijssel | 7500 | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided