AzTrials
AzTrials

Atrial FlutterNCT02591875

Atrial Flutter Ablation in a Real World Population

An observational study of Atrial Flutter, run by Azienda Ospedaliera Pugliese Ciaccio at 4 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Flutter
How many people
1,000 participants
Where
4 sitesItaly
Study dates
Oct 2015to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All consecutive patients, clinically indicated for an atrial flutter ablation, will be enrolled after signing of an informed consent form and an authorization to use and disclose health information.

Who may be able to join

  • Patient undergoing ablation of atrial flutter isthmus-dependent
  • Patient able to sign an authorization to use and disclose health information or an Informed Consent.
  • Patient available to attend scheduled follow-up visits at the center for at least 12 months

Who cannot join

  • Patient is participating in another clinical study that may have an impact on the study endpoints

Trial locations and contacts

4 sites in 1 country.

Giampiero Maglia, MD contact

0039 0963 531325

Clinical-leonardo@isis.it

Italy4 sites, 4 recruiting

  • Fondazione Poliambulanza - Istituto Ospedaliero

    Brescia, BS, 25124

    Domenico Pecora, MD

    Domenico Pecora, MD

    Recruiting

  • Azienda Ospedaliera Pugliese-Ciaccio

    Catanzaro, 88100

    Giampiero Maglia, MD

    Recruiting

  • Clinica Montevergine

    Mercogliano, AV, 83024

    Francesco Solimene, MD

    Francesco Solimene, MD

    Recruiting

  • Presidio Ospedaliero Policlinico Casilino

    Roma, RM, 00172

    Domenico Grieco, MD

    Leonardo Calò, Prof.

    Recruiting

Other trials in Italy

About this study

Official title: Atrial Flutter Ablation in a Real World Population: A Multicenter Italian Registry (The LEONARDO Study)

The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. The decision to perform the ablation of AFL will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. Patient time commitment for the study is approximately 12 months.The study has been designed to describe the italian clinical practice in relation to the approach of AFL ablation. In particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.

Read the detailed description

Catheter ablation of Atrial Flutter has become an accepted alternative to pharmacologic therapy.The current guidelines recommend the catheter ablation at the first episode of AFL (Class IIa) or in any case of recurrent episodes of AFL (Class I). Recent studies have already demonstrated a high degree of procedural efficacy (higher than 90%). However, there are still two main areas of investigation. First, what is the best method to obtain an effective lesion. Second, what is the most reliable method to validate the procedure success.The present study is aimed at investigating these aspects in the current Italian clinical practice.

Conditions
Atrial Flutter
Keywords
Cardiac Catheter Ablation, Cardiac Arrhythmias, Atrial Flutter
Medical subject headings
Atrial Flutter, Arrhythmias, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects With Complete Bidirectional Conduction Block

    Acute success is defined as the confirmation of complete bidirectional conduction block across the cavo-tricuspid isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.

    Measured: Time Frame: within 30 minutes after ablation procedure

Secondary outcomes (6)

  1. Recurrence of symptoms of AFL, measured as the proportion of patients reporting symptoms during follow-up

    number of patients with symptoms of AFL during follow-up

    Measured: 12 months

  2. Recurrence of AFL, measured as the proportion of patients with an episode longer than 30s documented at 24h Holter ECG recording during follow-up

    number of patients with recurrence of AFL documented at ECG recording during follow-up

    Measured: 12 months

  3. Lesion's validation criteria

    agreement between acute ablation success and long-term absence of AFL recurrence

    Measured: an average of 12 months following the ablation procedure

  4. Ablation procedure time

    • RadioFrequency time;
    • ablation time;
    • Fluoroscopy time

    Measured: intraoperative

  5. Acute adverse events

    Measured: intraoperative

  6. Adverse Events during Follow up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02591875
Sponsor's protocol ID
Protocollo n. 156 (06/11/2015)
Status last verified
Oct 2016
First submitted
7 Oct 2015
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Maglia G, Pentimalli F, Verlato R, Solimene F, Malacrida M, Aspromonte V, Bacino L, Turrini P, Infusino T, La Greca C, Perego GB, Papa AA, De Ruvo E, Zingarini G, Devecchi C, Scaglione M, Tomasi C, Pirrotta S, Stabile G. Ablation of CTI-dependent flutter using different ablation technologies: acute and long-term outcome from the LEONARDO study. J Interv Card Electrophysiol. 2023 Oct;66(7):1749-1757. doi: 10.1007/s10840-023-01519-7. Epub 2023 Mar 4.

    PubMed 36869990

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Flutter, run by Azienda Ospedaliera Pugliese Ciaccio at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giampiero Maglia, MD (0039 0963 531325, Clinical-leonardo@isis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Complete Bidirectional Conduction Block (time frame: Time Frame: within 30 minutes after ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02591875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in