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
| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.
This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QDOT Arm | Experimental | Temperature-controlled very-high-power short-duration ablation using the QDOT Micro catheter. |
|
| ST SF Arm | Active Comparator | Conventional high-power short-duration ablation using the ThermoCool ST SF catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QDOT Micro ablation catheter | Device | QDOT Micro ablation catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal change in esophageal temperature during posterior wall isolation. | During ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of esophageal thermal injury seen on post-procedure capsule endoscopy. | 2-4 days after ablation procedure. | |
| Presence of procedural complications. | During and immediately following ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of RF ablation lesions to performed pulmonary vein isolation. | During ablation procedure. | |
| RF time during pulmonary vein isolation. | During ablation procedure. | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric D Braunstein, MD | Contact | 310-248-6679 | Eric.Braunstein@cshs.org | |
| Tansy Aguilar | Contact | tansy.aguilar@cshs.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Smidt Heart Institute | Recruiting | Los Angeles | California | 90048 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2023 | Apr 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2024 | Apr 25, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Prospective open-label randomized controlled trial
Not provided
Not provided
Interpreters of the esophageal capsule endoscopy will be blinded to study group.
| ST SF ablation catheter |
| Device |
ST SF ablation catheter |
|
| Left atrial dwell time to achieve pulmonary vein isolation. |
| During ablation procedure. |
| Achievement of first pass pulmonary vein isolation. | During ablation procedure. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |