Ablation of Typical Right Atrial Flutter

Ablation of Typical Right Atrial Flutter Through the Arm: Evaluation of Safety, Feasibility, and Efficacy

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Flutter
• Intervention / Treatment: Procedure: Ablation through left arm; Procedure: Ablation through femoral vein

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aneesh Tolat, MD; Phone Number: 21506 8603716182; Email: aneesh.tolat@hhchealth.org
• Study Contact Backup: Name: Gregory Panza, PhD; Phone Number: 8609725799; Email: gregory.panza@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
      • Contact: Aneesh Tolat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation through upper extremity; Ablation through arm	Procedure: Ablation through left arm; Ablation through left arm
Active Comparator: Ablation through femoral vein; Ablation through vein	Procedure: Ablation through femoral vein; Ablation through femoral vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Aneesh Tolat, MD, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: safety; efficacy; ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: HHC20200300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No