An observational study in Typical Atrial Flutter, sponsored by Ospedale San Francesco. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Ospedale San Francesco · Observational
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
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:
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.
213 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.
This study's planned enrollment of 400 is above the median of 232 across 59 observational studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →This is the only study on the registry with Ospedale San Francesco as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Caucasian population regardless gender
Exclusion Criteria:
Ablation point by point on the cavo tricuspid isthmus guided by an index lesion
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
Time frame: 9 months
radiofrequency time of application
reduction in radio frequency time in comparison with current literature
Time frame: 9 months
Near zero x ray
reduction of x-ray time
Time frame: 9 months
Procedural time
reduction in procedural time in comparison with current literature
Time frame: 9 months
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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