Recruiting

Ablation

Sponsor:

Hartford Hospital

Code:

NCT05755074

Conditions

Atrial Flutter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ablation through left arm

Ablation through femoral vein

Study Details

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 ID

NCT05755074

Start date

Oct 28, 2021

Status verified date

Feb, 2024

Completion date

Apr, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ablation through upper extremity

Ablation through arm

active comparator: Ablation through femoral vein

Ablation through vein

Interventions

Ablation through left arm

Ablation through left arm

Ablation through femoral vein

Ablation through femoral vein

Primary outcome measure

  • Recovery time [ Time Frame: Immediately after procedure ]

Central Contacts and Locations

Central contacts

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

More Information

Sponsor

Hartford Hospital

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Keywords

  • ablation
  • safety
  • efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2024-02-28.