Typical Atrial Flutter, Ablation Index and Point by Point Ablation

NCT ID: NCT03867266

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2019-07-01

Brief 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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ablation with radiofrequency

Ablation point by point on the cavo tricuspid isthmus guided by an index lesion

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Francesco

OTHER

Sponsor Role: lead

Responsible Party

Graziana Viola

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Francesco

Nuoro, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Graziana Viola, Medicine

Role: CONTACT

grazianaviola@gmail.com

+393401403816

Facility Contacts

Graziana Viola, Medicine

Role: primary

grazianaviola@gmail.com

+390784240108

Gavino Casu, Medicine

Role: backup

gcasu61@gmail.com

+390784240103

Other Identifiers

73/2018

Identifier Type: -

Identifier Source: org_study_id