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Typical atrial flutter ablation involving forming a line of block across the cavotricuspid isthmus in the right atrium has become a commonly performed procedure and is considered a class I indicated procedure for patients who wish to pursue maintenance of sinus rhythm. The ablation generally involves 2-3 catheters and is typically performed through the femoral vein(s). After the ablation procedure, the patient is placed on bed rest for 4 hours, and typically discharged home the same day on oral anticoagulation.
Catheter technology has improved over the past several years allowing for more rapid ablation with shorter procedure times. Ultrasound has also become more routinely used when obtaining venous access for the patient.
To date, ablation of typical atrial flutter through the left or right arm has not been reported. Diagnostic electrophysiology studies have been performed through the arm and AV node ablation has also been reported from the cephalic, internal jugular, axillary and subclavian veins. The potential benefits include shorter recovery time, reduced risk of retroperitoneal bleed, and the avoidance of access complications from the groin.
This study aims to evaluate the safety, feasibility, and efficacy of performing typical atrial flutter ablation through the arm.
Specifically, the study will aim to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation through upper extremity | Experimental | Ablation through arm |
|
| Ablation through femoral vein | Active Comparator | Ablation through vein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation through left arm | Procedure | Ablation through left arm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | Recovery time after procedure is defined as clock time when the patient is deemed ready for discharge minus clock time when the patient's procedure has ended | Immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | Percentage of patients with ablation leading to evidence of bidirectional block | Measured during procedure |
| Frequency of complications | Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aneesh Tolat, MD | Contact | 8603716182 | 21506 | aneesh.tolat@hhchealth.org |
| Gregory Panza, PhD | Contact | 8609725799 | gregory.panza@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Aneesh Tolat, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Ablation through femoral vein |
| Procedure |
Ablation through femoral vein |
|
| Measured during procedure |
| Complication rate | Percentage of patient with complications after ablation for atrial flutter | Measured during procedure |
| One month success rate | Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter | Measured at one month after ablation |
| One year success rate | Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter | Measured at one year after ablation |
| Pain severity scale | The pain severity scale measures pain on a scale of 1 to 10 (10 being extremely painful, 1 being no pain). Patients will be asked "how much pain are you feeling at the site in which the catheter was inserted?" and will give an answer from 0 to 10, as described above. | Measured once at discharge |
| D013568 |
| Pathological Conditions, Signs and Symptoms |