Typical Atrial Flutter, Ablation Index and Point by Point Ablation (NCT03867266) | Clinical Trial Compass
UnknownNot Applicable
Typical Atrial Flutter, Ablation Index and Point by Point Ablation
Italy400 participantsStarted 2019-02-20
Plain-language 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
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.