NCT02591875

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

5.2 years

First QC Date

October 7, 2015

Last Update Submit

October 18, 2016

Conditions

Atrial Flutter

Keywords

Cardiac Catheter AblationCardiac ArrhythmiasAtrial Flutter

Outcome Measures

Primary Outcomes (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.

    Time Frame: within 30 minutes after ablation procedure

Secondary Outcomes (6)

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

    12 months

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

    12 months

  • Lesion's validation criteria

    an average of 12 months following the ablation procedure

  • Ablation procedure time

    intraoperative

  • Acute adverse events

    intraoperative

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinica Montevergine

Mercogliano, AV, 83024, Italy

RECRUITING

Fondazione Poliambulanza - Istituto Ospedaliero

Brescia, BS, 25124, Italy

RECRUITING

Presidio Ospedaliero Policlinico Casilino

Roma, RM, 00172, Italy

RECRUITING

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, 88100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36869990DERIVED

MeSH Terms

Conditions

Atrial FlutterArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Giampiero Maglia, MD

CONTACT

0039 0963 531325Clinical-leonardo@isis.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Electrophysiology and Cardiac Pacing

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

IT(4)