Ablation of Typical Right Atrial Flutter

Not Applicable

Recruiting

• Conditions: Atrial Flutter
• Interventions: Procedure: Ablation through left arm; Procedure: Ablation through femoral vein

• Registration Number: NCT05755074
• Lead Sponsor: Hartford Hospital

Brief Summary

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:

1. Compare the recovery time immediately after the procedure using upper extremity access compared to the standard approach.

2. Compare the success rate of patients that undergo ablation of typical atrial flutter through the upper extremity venous system (experimental approach) to the standard approach (i.e., through the femoral vein(s). Success will be defined as ablation that leads to evidence for bidirectional block across the right atrial cavotricuspid isthmus.

3. Establish what the potential complications are from performing typical atrial flutter through the left or right arm. The left arm will be the preferred site for access because of less tortuosity to reach the heart. If one side cannot be accessed the alternate arm will be used, but will be left to the discretion of the operator. The operator will have the discretion to switch to a femoral approach at any time.

4. Compare the complication rates of the experimental approach evaluated by the inability to access the vein, and other complications (e.g., bleeding, vein thrombosis, heart perforation) from accessing the vein in the arm to the complication rates of the standard approach.

5. Compare long term (i.e., 1 month and 1 year) success of the experimental approach vs. the standard approach as assessed by maintenance of normal sinus rhythm, without recurrent typical right atrial flutter with in person visits and phone call or chart evaluations.

6. Compare pain severity of the insertion site between the experimental and standard approaches.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-20
• Study Start: 2021-10-28
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Referred to the EP lab for typical right atrial flutter ablation as an outpatient
• Bodyweight of 50Kg (110 lb) or above
• Documented typical atrial flutter by 12 lead EKG or telemetry

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Exclusion Criteria

• Bodyweight less than 50 Kg
• Inability to provide consent
• Presence of pacemaker or defibrillator with transvenous leads
• Inpatient admission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation through upper extremity	Ablation through left arm	Ablation through arm
Ablation through femoral vein	Ablation through femoral vein	Ablation through vein

Primary Outcome Measures

Name	Time	Method
Recovery time	Immediately after procedure	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

Secondary Outcome Measures

Name	Time	Method
Success rate	Measured during procedure	Percentage of patients with ablation leading to evidence of bidirectional block
One month success rate	Measured at one month after ablation	Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Complication rate	Measured during procedure	Percentage of patient with complications after ablation for atrial flutter
Pain severity scale	Measured once at discharge	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.
Frequency of complications	Measured during procedure	Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm.
One year success rate	Measured at one year after ablation	Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States