ClinicalTrials.gg
RecruitingNCT05755074Updated Feb 28, 2024

Ablation of Typical Right Atrial Flutter

An interventional study of Ablation through left arm and Ablation through femoral vein in Atrial Flutter, sponsored by Hartford Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Atrial Flutter

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Keywords

  • ablation
  • safety
  • efficacy
03

In context

Atrial Flutter

223 studies on the registry are indexed under Atrial Flutter; 51 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 155 interventional studies indexed under Atrial Flutter.

Browse Atrial Flutter studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or telemetry

Exclusion criteria

Exclusion Criteria:

  • Bodyweight less than 50 Kg
  • Inability to provide consent
  • Presence of pacemaker or defibrillator with transvenous leads
  • Inpatient admission
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ablation through upper extremity

    Ablation through arm

    Procedure: Ablation through left arm

  • Active comparator
    Ablation through femoral vein

    Ablation through vein

    Procedure: Ablation through femoral vein

Interventions

  • ProcedureAblation through left arm

    Ablation through left arm

  • ProcedureAblation through femoral vein

    Ablation through femoral vein

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Immediately after procedure

Secondary outcomes

  1. Success rate

    Percentage of patients with ablation leading to evidence of bidirectional block

    Time frame: Measured during procedure

  2. Frequency of complications

    Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm.

    Time frame: Measured during procedure

  3. Complication rate

    Percentage of patient with complications after ablation for atrial flutter

    Time frame: Measured during procedure

  4. One month success rate

    Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter

    Time frame: Measured at one month after ablation

  5. One year success rate

    Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter

    Time frame: Measured at one year after ablation

  6. 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.

    Time frame: Measured once at discharge

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05755074
Lead sponsor
Hartford Hospital
Responsible party
Sponsor
First posted
Mar 6, 2023
Start date
Oct 28, 2021
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Feb 28, 2024

Study contacts

Aneesh Tolat, MD
Contact
aneesh.tolat@hhchealth.org
8603716182 ext. 21506
Gregory Panza, PhD
Contact
gregory.panza@hhchealth.org
8609725799
Aneesh Tolat, MD
principal investigator · Hartford Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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