RECRUITING

Ablation of Typical Right Atrial Flutter

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-28
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05755074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Referred to the EP lab for typical right atrial flutter ablation as an outpatient
  2. * Bodyweight of 50Kg (110 lb) or above
  3. * Documented typical atrial flutter by 12 lead EKG or telemetry
  1. * Bodyweight less than 50 Kg
  2. * Inability to provide consent
  3. * Presence of pacemaker or defibrillator with transvenous leads
  4. * Inpatient admission

Contacts and Locations

Study Contact

Aneesh Tolat, MD
CONTACT
8603716182
aneesh.tolat@hhchealth.org
Gregory Panza, PhD
CONTACT
8609725799
gregory.panza@hhchealth.org

Principal Investigator

Aneesh Tolat, MD
PRINCIPAL_INVESTIGATOR
Hartford Hospital

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06102
United States

Collaborators and Investigators

Sponsor: Hartford Hospital

  • Aneesh Tolat, MD, PRINCIPAL_INVESTIGATOR, Hartford Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-28
Study Completion Date2025-04

Study Record Updates

Study Start Date2021-10-28
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • ablation
  • safety
  • efficacy

Additional Relevant MeSH Terms

  • Atrial Flutter