Typical Atrial FlutterFLAINCT03867266
Typical Atrial Flutter, Ablation Index and Point by Point Ablation
An observational study of Typical Atrial Flutter, run by Ospedale San Francesco at 1 site in Italy.
Trial summary
The Ablation of the typical atrial flutter can be considered substantially anatomical, the investigators want to test a protocol that foresees the use a lesion index (AI) and that respects the Inter-Lesion Distance (ILD) ≤ 6 mm on the cavo-tricuspid isthmus (CTI) The investigators want to prove how the introduction of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Typical Atrial Flutter
- What is being tested?
- Ablation with radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2019to 1 Jul 2019
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian population regardless gender
Who may be able to join
- paroxysmal, persistent and /or long standing atrial flutter even in the presence of structural heart disease
- Informed consent form
- Age equal or above 18 years
- Skilled and willing to comply with all tests and follow up requirements
- Patients that ,in the context of ablation for fibrillation atrial, should also undergo to typical flutter ablation: in this case the data collected will be those related to typical flutter ablation.
Who cannot join
- Previous ablation for atrial flutter
- Atrial flutter secondary to electrolyte imbalance, thyroid disease or to a reversible or non-cardiac cause
- severe anemia,
- sepsis in progress
- Bypass procedure with coronary arterial artery in the last three months
- Pending cardiac transplantation or other cardiac surgery
Show all 14Show fewer
- Pregnant or breastfeeding women
- Acute disease or active systemic infection or sepsis
- Documented left atrial thrombus
- Unstable angina
- Uncontrolled heart failure
- Life expectancy of less than 12 months
- Registration in any other study evaluating another device or medication
- Presence of intramural thrombi, tumor or other anomalies that preclude the introduction of the catheter into the vein system
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Francesco
Nuoro, 08100
Graziana Viola, Medicine, +390784240108, grazianaviola@gmail.com
Gavino Casu, Medicine, +390784240103, gcasu61@gmail.com
About this study
The Ablation of the typical atrial flutter can be considered substantially anatomical, the investigators want to test a protocol that foresees the use a lesion index (AI) and that respects the Inter-Lesion Distance (ILD) ≤ 6 mm on the cavo-tricuspid isthmus (CTI) The investigators want to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency (RF) times
Read the detailed description
The Ablation of the typical atrial flutter can be considered substantially anatomical, the aim of the study is to test a protocol that foresees the use a lesion index and that respects the Inter-Lesion Distance ≤ 6 mm on the cavo-tricuspid isthmus to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency times With the aim of reducing the use of the fluoroscopy and ionizing radiations, an anatomical map of the right atrium will be reconstructed with a mapping catheter in all patients, and a 10-pole catheter will be placed in the coronary sinus.Then, the anatomy of the isthmus will be precisely defined with a catheter equipped with a force sensor ,identifying the tricuspid valve as the initial point of ablation and the inferior vena cava- right atrium junction as the end point of the line.Once the reconstruction has been completed, the ablation phase will start. Considering the values already validated for the left atrium, the protocol foresees the point-by-point ablation with the use of AI ≥ 500 and ILD≤ 6 mm.
The Visitag setting will be the following:
- Respiration Adjustment;
- Catheter Position Stability Min. Time = 3 sec, Max. Range = 5 mm;
- Force Over Time Time = 30% Min. Force = 4 gr. The power can be set between 35 and 40 watts. At the end of the isthmus ablation, line block will be evaluated by proximal CS pacing, acquiring at least 3 distinct points from the ablator catheter around the tricuspid annulus ,typically ostium of coronary sinus (CS), lateral tricuspid annulus and a point more proximal to the line of ablation.
Once this phase has been completed, 20 minutes of waiting time has to be considered. After this waiting time the block of the isthmus will be validated again with the same protocol described above.
Primary Endpoint -Anatomical first Pass block of the CTI.
Secondary Endpoint
-Reduction of procedural, RF and fluoroscopy times.
- Conditions
- Typical Atrial Flutter
- Being tested
- Ablation with radiofrequency
- Keywords
- Ablation index, Interlesion distance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation with radiofrequencyProcedure or surgery
Ablation point by point on the cavo tricuspid isthmus guided by an index lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass block of the cavo tricuspid isthmus
Validation of the bidirectional block by pacing on the coronary sinus after completing the first line of the ablation
Measured: 9 months
Secondary outcomes (3)
radiofrequency time of application
reduction in radio frequency time in comparison with current literature
Measured: 9 months
Near zero x ray
reduction of x-ray time
Measured: 9 months
Procedural time
reduction in procedural time in comparison with current literature
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start20 Feb 2019
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Francesco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graziana Viola, Ospedale San Francesco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867266
- Sponsor's protocol ID
- 73/2018
- Acronym
- FLAI
- Status last verified
- Mar 2019
- First submitted
- 11 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typical Atrial Flutter, Ablation Index and Point by Point Ablation
- ClinicalTrials.gov ID
- NCT03867266
- Acronym / sponsor ID
- FLAI / 73/2018
- Conditions
- Typical Atrial Flutter
- Keywords
- Ablation index, Interlesion distance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ospedale San FrancescoUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 7 Mar 2019 (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.
The Ablation of the typical atrial flutter can be considered substantially anatomical, the investigators want to test a protocol that foresees the use a lesion index (AI) and that respects the Inter-Lesion Distance (ILD) ≤ 6 mm on the cavo-tricuspid isthmus (CTI) The investigators want to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency (RF) times
Detailed description
The Ablation of the typical atrial flutter can be considered substantially anatomical, the aim of the study is to test a protocol that foresees the use a lesion index and that respects the Inter-Lesion Distance ≤ 6 mm on the cavo-tricuspid isthmus to prove how the introduction of a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency times With the aim of reducing the use of the fluoroscopy and ionizing radiations, an anatomical map of the right atrium will be reconstructed with a mapping catheter in all patients, and a 10-pole catheter will be placed in the coronary sinus.Then, the anatomy of the isthmus will be precisely defined with a catheter equipped with a force sensor ,identifying the tricuspid valve as the initial point of ablation and the inferior vena cava- right atrium junction as the end point of the line.Once the reconstruction has been completed, the ablation phase will start. Considering the values already validated for the left atrium, the protocol foresees the point-by-point ablation with the use of AI ≥ 500 and ILD≤ 6 mm.
The Visitag setting will be the following:
- Respiration Adjustment;
- Catheter Position Stability Min. Time = 3 sec, Max. Range = 5 mm;
- Force Over Time Time = 30% Min. Force = 4 gr. The power can be set between 35 and 40 watts. At the end of the isthmus ablation, line block will be evaluated by proximal CS pacing, acquiring at least 3 distinct points from the ablator catheter around the tricuspid annulus ,typically ostium of coronary sinus (CS), lateral tricuspid annulus and a point more proximal to the line of ablation.
Once this phase has been completed, 20 minutes of waiting time has to be considered. After this waiting time the block of the isthmus will be validated again with the same protocol described above.
Primary Endpoint -Anatomical first Pass block of the CTI.
Secondary Endpoint
-Reduction of procedural, RF and fluoroscopy times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian population regardless gender
Key inclusion criteria (5 listed)
- paroxysmal, persistent and /or long standing atrial flutter even in the presence of structural heart disease
- Informed consent form
- Age equal or above 18 years
- Skilled and willing to comply with all tests and follow up requirements
- Patients that ,in the context of ablation for fibrillation atrial, should also undergo to typical flutter ablation: in this case the data collected will be those related to typical flutter ablation.
Key exclusion criteria (14 listed)
- Previous ablation for atrial flutter
- Atrial flutter secondary to electrolyte imbalance, thyroid disease or to a reversible or non-cardiac cause
- severe anemia,
- sepsis in progress
- Bypass procedure with coronary arterial artery in the last three months
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 with radiofrequencyAblation point by point on the cavo tricuspid isthmus guided by an index lesion | Procedure or surgery | – |
Primary outcome
First pass block of the cavo tricuspid isthmus
Time frame: 9 months
Validation of the bidirectional block by pacing on the coronary sinus after completing the first line of the ablation
3 secondary outcomes
radiofrequency time of application
Time frame: 9 months
Near zero x ray
Time frame: 9 months
Procedural time
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Typical Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical
Not yet recruiting
Prophylactic Pulmonary Vein Isolation During Atrial Flutter Ablation
Atrial Flutter Typical
Recruiting
Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation
Catheter Ablation, Atrial Flutter Typical
Not yet recruiting
Clinical Study on the Efficiency of Rapid Arrhythmia Mapping Using EasyStars™ High Density Mapping Catheter Applications
Ventricular Tachycardia (VT), Atrial Tachycardia
Recruiting
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia
Typical Atrial Flutter, Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Typical Atrial Flutter, run by Ospedale San Francesco at 1 site in Italy.
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 5 inclusion and 14 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 7 Mar 2019. 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 Italy. 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 Graziana Viola, Medicine (+393401403816, grazianaviola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass block of the cavo tricuspid isthmus (time frame: 9 months). 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 7 Mar 2019.