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| Name | Class |
|---|---|
| Thorax Centrum Twente | OTHER |
| Academisch Ziekenhuis Maastricht | OTHER |
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Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
Main study parameters/endpoints Acute success of pulmonary vein isolation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 times 1 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute |
|
| 2 times 2 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes |
|
| 2 times 3 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon ablation | Other | PVI using cryoballoon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients wit successfull pulmonary vein isolation | Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure. | up to 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications | Complications being:
| 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Nederland | 7500 KA | Netherlands | ||
| Maastricht University Medical Centre |
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| Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present |
The assessment of this outcome will take place during the procedure |
| up to 6 minutes |
| Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation | The assessment of this outcome will take place during the procedure. | up to 6 minutes |
| Procedure time, fluoroscopy time, amount of contrast used | The assessment of this outcome will take place right after the procedure. It measures procedural parameters. | up to 6 minutes |
| Lower Esophageal Temperature development | The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure. | up to 6 minutes |
| Atrial Fibrillation recurrence | after 1 year follow up |
| Balloon temperatures measured by the console | up to 6 minutes |
| Maastricht |
| 6229 HX |
| Netherlands |
| 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 |
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