Typical Atrial Flutter, Ablation Index and Point by Point Ablation

Typical Atrial Flutter Clinical Trial

— FLAI  

Official title:

Typical Atrial Flutter, Ablation Index and Point by Point Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03867266
• Other study ID #: 73/2018
• Status: Recruiting
• Start date: February 20, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2019
• Source: Ospedale San Francesco
• Contact: Graziana Viola, Medicine
• Phone: +393401403816
• Email: grazianaviola[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 a lesion index combined with the continuity of lesion can allow a "first pass block" of the CTI decreasing total Radio-Frequency (RF) times

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Atrial Flutter
• Typical Atrial Flutter

Intervention

Procedure:
• Ablation with radiofrequency
Ablation point by point on the cavo tricuspid isthmus guided by an index lesion

Locations

Country	Name	City	State
Italy	Ospedale San Francesco	Nuoro

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Francesco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 months
Secondary	radiofrequency time of application	reduction in radio frequency time in comparison with current literature	9 months
Secondary	Near zero x ray	reduction of x-ray time	9 months
Secondary	Procedural time	reduction in procedural time in comparison with current literature	9 months