Taking people in ItalyNo phase

Tests a high-power short-burst heart ablation for irregular heartbeat

Follows adults with atrial fibrillation treated with high-power short-duration catheter ablation.

Key facts

Who runs it: Clinica Mediterranea
Where: Ancona, Asti, Conegliano, Cotignola, Mercogliano, Naples, and Torino, ItalySee the 7 sitesAlso in 2 other countries, 2 sites
Trial code: NCT05777551
Registry title: AF Ablation With High Power Short Duration RF
Status: Recruiting
People taking part: 850 people, planned
Started: 1 Jan 2023
Expected to end: 31 Dec 2027
Type of study: Observational
Record updated: 5 March 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are taking blood-thinning tablets and will have a catheter ablation using high power short duration radiofrequency energy.

Age: 18 to 80 years
Sex: All sexes can join.
Disease stage: Paroxysmal or persistent atrial fibrillation (AF).
Earlier treatment: Must be taking oral anticoagulation (blood thinners). Must not have had an ablation for AF before.

Main reasons for not taking part

Previous ablation for AF
Heart pumping function (LVEF) below 35%
Women who could potentially be pregnant
Cannot be exposed to X-rays
Congenital heart disease or heart surgery within the last 1 month

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

Patients with paroxysmal/persistent AF who signed the informed consent
Patients on active oral anticoagulation

Who cannot take part

Previous ablation for AF
Congenital heart disease or cardiac surgery within 1 month
Patients with LVEF<35%
Women potentially pregnant
Contraindications to X-ray exposure

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in Italy

Also in 2 other countries, 2 sites

Universita Politecnica Delle MarcheAncona, ItalyContact: Michela CasellaTaking people
Ospedale Civile di AstiAsti, ItalyContact: Marco ScaglioneTaking people
Ospedale di ConeglianoConegliano, ItalyContact: Roberto Mantovan, MDTaking people
Maria Cecilia HospitalCotignola, ItalyContact: Saverio IacopinoTaking people
Clinica MontevergineMercogliano, ItalyContact: Francesco SolimeneTaking people
Clinica MediterraneaNaples, ItalyContact: Giuseppe StabileTaking people
Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.Torino, ItalyContact: Matteo AnselminoNot yet recruiting

About the trial

What the trial wants to find out

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF).

Read full original descriptionShow less

Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).

Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.

At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R\^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.