Ablation of Typical Right Atrial Flutter

NCT05755074 | Recruiting

• 1 other identifier: HHC20200300
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Compare the recovery time immediately after the procedure using upper extremity access compared to the standard approach.
2. 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. 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. 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. 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. 6.Compare pain severity of the insertion site between the experimental and standard approaches.

Conditions

Atrial Flutter

Keywords

ablation; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Success rate

  Measured during procedure

• Frequency of complications

  Measured during procedure

• Complication rate

  Measured during procedure

• One month success rate

  Measured at one month after ablation

• One year success rate

  Measured at one year after ablation

Study Arms (2)

Ablation through upper extremity

EXPERIMENTAL

Ablation through arm

Procedure: Ablation through left arm

Ablation through femoral vein

ACTIVE COMPARATOR

Ablation through vein

Procedure: Ablation through femoral vein

Interventions

Ablation through left arm PROCEDURE

Ablation through left arm

Ablation through upper extremity

Ablation through femoral vein PROCEDURE

Ablation through femoral vein

Ablation through femoral vein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aneesh Tolat, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aneesh Tolat, MD

CONTACT

8603716182; aneesh.tolat@hhchealth.org

Gregory Panza, PhD

CONTACT

8609725799; gregory.panza@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: March 6, 2023
• Study Start: October 28, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)