Ablation of Typical Right Atrial Flutter
Primary Purpose
Atrial Flutter
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation through left arm
Ablation through femoral vein
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring ablation, safety, efficacy
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
Sites / Locations
- Hartford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ablation through upper extremity
Ablation through femoral vein
Arm Description
Ablation through arm
Ablation through vein
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Success rate
Percentage of patients with ablation leading to evidence of bidirectional block
Frequency of complications
Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm.
Complication rate
Percentage of patient with complications after ablation for atrial flutter
One month success rate
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
One year success rate
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Pain severity scale
The pain severity scale measures pain on a scale of 1 to 10 (10 being extremely painful, 1 being no pain). Patients will be asked "how much pain are you feeling at the site in which the catheter was inserted?" and will give an answer from 0 to 10, as described above.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05755074
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
Compare the recovery time immediately after the procedure using upper extremity access compared to the standard approach.
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.
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.
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.
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.
Compare pain severity of the insertion site between the experimental and standard approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
ablation, safety, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation through upper extremity
Arm Type
Experimental
Arm Description
Ablation through arm
Arm Title
Ablation through femoral vein
Arm Type
Active Comparator
Arm Description
Ablation through vein
Intervention Type
Procedure
Intervention Name(s)
Ablation through left arm
Intervention Description
Ablation through left arm
Intervention Type
Procedure
Intervention Name(s)
Ablation through femoral vein
Intervention Description
Ablation through femoral vein
Primary Outcome Measure Information:
Title
Recovery time
Description
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
Time Frame
Immediately after procedure
Secondary Outcome Measure Information:
Title
Success rate
Description
Percentage of patients with ablation leading to evidence of bidirectional block
Time Frame
Measured during procedure
Title
Frequency of complications
Description
Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm.
Time Frame
Measured during procedure
Title
Complication rate
Description
Percentage of patient with complications after ablation for atrial flutter
Time Frame
Measured during procedure
Title
One month success rate
Description
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Time Frame
Measured at one month after ablation
Title
One year success rate
Description
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Time Frame
Measured at one year after ablation
Title
Pain severity scale
Description
The pain severity scale measures pain on a scale of 1 to 10 (10 being extremely painful, 1 being no pain). Patients will be asked "how much pain are you feeling at the site in which the catheter was inserted?" and will give an answer from 0 to 10, as described above.
Time Frame
Measured once at discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aneesh Tolat, MD
Phone
8603716182
Ext
21506
Email
aneesh.tolat@hhchealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Panza, PhD
Phone
8609725799
Email
gregory.panza@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneesh Tolat, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneesh Tolat, MD
12. IPD Sharing Statement
Learn more about this trial
Ablation of Typical Right Atrial Flutter
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