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.
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
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Aneesh Tolat, MD
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Ablation through upper extremity | Experimental | Ablation through arm Receives: Procedure: Ablation through left arm |
| Ablation through femoral vein | Active comparator | Ablation 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.
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)
Success rate
Percentage of patients with ablation leading to evidence of bidirectional block
Measured: Measured during procedure
Frequency of complications
Frequency of complications that arise from performing ablation for atrial flutter through the left or right arm.
Measured: Measured during procedure
Complication rate
Percentage of patient with complications after ablation for atrial flutter
Measured: Measured during procedure
One month success rate
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Measured: Measured at one month after ablation
One year success rate
Percentage of patients maintaining normal sinus rhythm, without recurrent typical right atrial flutter
Measured: Measured at one year after ablation
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.
- First posted6 Mar 2023
- Study start28 Oct 2021
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneesh Tolat, MD, Principal investigator, Hartford Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Typical Right Atrial Flutter Through the Arm: Evaluation of Safety, Feasibility, and Efficacy
- ClinicalTrials.gov ID
- NCT05755074
- Acronym / sponsor ID
- HHC20200300
- Conditions
- Atrial Flutter
- Keywords
- ablation, safety, efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation through upper extremity | Experimental | Procedure: Ablation through left armAblation through arm |
| Ablation through femoral vein | Active comparator | Procedure: Ablation through femoral veinAblation through vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Bodyweight less than 50 Kg
- Inability to provide consent
- Presence of pacemaker or defibrillator with transvenous leads
- Inpatient admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation through left armAblation through left arm | Procedure or surgery | Ablation through upper extremity |
| Ablation through femoral veinAblation through femoral vein | Procedure or surgery | Ablation through femoral vein |
Primary outcome
Recovery time
Time frame: 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
6 secondary outcomes
Success rate
Time frame: Measured during procedure
Frequency of complications
Time frame: Measured during procedure
Complication rate
Time frame: Measured during procedure
One month success rate
Time frame: Measured at one month after ablation
One year success rate
Time frame: Measured at one year after ablation
Pain severity scale
Time frame: Measured once at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneesh Tolat, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
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.