Ablation of Typical Right Atrial Flutter

NCT ID: NCT05755074

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2025-04-30

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.

Conditions

Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablation through upper extremity

Ablation through arm

Group Type: EXPERIMENTAL

Ablation through left arm

Intervention Type: PROCEDURE

Ablation through left arm

Ablation through femoral vein

Ablation through vein

Group Type: ACTIVE_COMPARATOR

Ablation through femoral vein

Intervention Type: PROCEDURE

Ablation through femoral vein

Interventions

Ablation through left arm

Ablation through left arm

Intervention Type: PROCEDURE

Ablation through femoral vein

Ablation through femoral vein

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aneesh Tolat, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aneesh Tolat, MD

Role: CONTACT

aneesh.tolat@hhchealth.org

8603716182 ext. 21506

Gregory Panza, PhD

Role: CONTACT

gregory.panza@hhchealth.org

8609725799

Facility Contacts

Aneesh Tolat, MD

Role: primary

Other Identifiers

HHC20200300

Identifier Type: -

Identifier Source: org_study_id