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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.
Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-fluoroscopic Cryoballoon PVI | Experimental |
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| Fluoroscopic Cryoballoon PVI | Active Comparator | Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon Pulmonary Vein Isolation - PVI | Procedure | A 28-mm cryoballoon (Arctic Front Advanceâ„¢ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation. | change in the composite endpoint of total fluoroscopy time (min) | one year |
| Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation. | change in the composite endpoint of contrast (cc) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | •recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours) | one year |
| Time to Cryoballoon Pulmonary Vein Isolation |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Condition or Disease: Paroxysmal atrial fibrillation
Procedure: Cryoballoon Pulmonary Vein Isolation
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Subjects will be randomized in a 2:1 fashion
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•cryoballoon procedure time (min) |
| one year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |