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Atrial FlutterNCT05755074

Ablation of Typical Right Atrial Flutter

A study testing Ablation through left arm and Ablation through femoral vein in people with Atrial Flutter, run by Hartford Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Flutter
What is being tested?
Ablation through left arm and Ablation through femoral vein
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
28 Oct 2021to Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Hartford Hospital

    Hartford, Connecticut, 06102

    Aneesh Tolat, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read more

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.
Conditions
Atrial Flutter
Being tested
Ablation through left arm, Ablation through femoral vein
Keywords
ablation, safety, efficacy
Medical subject headings
Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation through left armProcedure or surgery

    Ablation through left arm

  • Ablation through femoral veinProcedure or surgery

    Ablation through femoral vein

Study groups in NCT05755074
Study groupRoleWhat they receive
Ablation through upper extremityExperimentalAblation through arm
Receives: Procedure: Ablation through left arm
Ablation through femoral veinActive comparatorAblation through vein
Receives: Procedure: Ablation through femoral vein

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately after procedure

Secondary outcomes (6)
  1. Success rate

    Percentage of patients with ablation leading to evidence of bidirectional block

    Measured: Measured during procedure

  2. Frequency of complications

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

    Measured: Measured during procedure

  3. Complication rate

    Percentage of patient with complications after ablation for atrial flutter

    Measured: Measured during procedure

  4. One month success rate

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

    Measured: Measured at one month after ablation

  5. One year success rate

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

    Measured: 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.

    Measured: Measured once at discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start28 Oct 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755074
Sponsor's protocol ID
HHC20200300
Status last verified
Feb 2024
First submitted
20 Oct 2020
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ablation through left arm and Ablation through femoral vein in people with Atrial Flutter, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aneesh Tolat, MD (8603716182 ext. 21506, aneesh.tolat@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery time (time frame: Immediately after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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