Clinical trial NCT05755074: Ablation of Typical Right Atrial Flutter
Official title: Ablation of Typical Right Atrial Flutter Through the Arm: Evaluation of Safety, Feasibility, and Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Flutter
Keywords: ablation
safety
efficacy
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recovery time
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Success rate
timeFrame: Measured during procedure
measure: Frequency of complications
timeFrame: Measured during procedure
measure: Complication rate
timeFrame: Measured during procedure
measure: One month success rate
timeFrame: Measured at one month after ablation
measure: One year success rate
timeFrame: Measured at one year after ablation
measure: Pain severity scale
timeFrame: Measured once at discharge
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Aneesh Tolat, MD
role: PRINCIPAL_INVESTIGATOR
References: