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临床试验/NCT05755074
NCT05755074招募中不适用

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

Hartford Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Recovery time

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Ablation through upper extremity

Experimental

Ablation through arm

干预措施: Ablation through left arm (Procedure)

Ablation through femoral vein

Active Comparator

Ablation through vein

干预措施: Ablation through femoral vein (Procedure)

结局指标

主要结局

Recovery time

时间窗: Immediately after procedure

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

次要结局

  • Success rate(Measured during procedure)
  • One month success rate(Measured at one month after ablation)
  • Complication rate(Measured during procedure)
  • Pain severity scale(Measured once at discharge)
  • Frequency of complications(Measured during procedure)
  • One year success rate(Measured at one year after ablation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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