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Driver-guided Ablation of Persistent Atrial Fibrillatiom

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ClinicalTrials.gov Identifier: NCT04085731
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Brief Summary:
This is a prospective, single-center, study. A targeted number of 181patients with persistent AF will be included according to pre-defined criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated mapping technique. We hypothesize that such approach may potentially lead to a mechanisms-targeted ablation strategy of persistent AF.

Condition or disease Intervention/treatment
Novel Approach for Catheter Ablation of Persistent Atrial Fibrillation Procedure: Catheter ablation

Detailed Description:
This is a prospective, single-center, study enrolling a total of 181patients with persistent AF according to well defined inclusion and exclusion criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated 3D mapping technique followed by standard CPVA at the end of the procedure. We will ablate substrates showing fast and regular electrical activities, starting from areas with the fastest mean cycle length and/or areas that have consistent rotational or focal propagation pattern and/or areas that comprise the slow conduction zone of possible arrhythmia circuits. After substrate ablation and AF termination, arrhythmia inducibility will be assessed and, if not inducible, the procedure will be completed by standard CPVA. If AF is still inducible, a new 3D map will be performed to identify further targets to be eliminated. Electrical cardioversion may be done at the end of the procedure. We hypothesized that such approach may potentially lead to a mechanisms-targeted ablation strategy leading to elimination of arrhythmic sources in individual patients, thus improving their clinical outcome. We will also characterize, identify and target the real pathophysiological substrates. After ablation, AF recurrence will be assessed by implantable loop recorder or thans-telephonic ECG recording from the end of the 3 months blanking period to 12 months following the procedure.The duration of this study is expected to be 24 months, from the first patient enrollment to the last patient follow-up.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 181 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Driver-guided Ablation in the Treatment of Persistent Atrial Fibrillation
Estimated Study Start Date : September 21, 2019
Estimated Primary Completion Date : September 21, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Catheter ablation
    Driver-guided catheter ablation of persistent atrial fibrillation


Primary Outcome Measures :
  1. Freedom from any AF or atrial tachycardia assessed from the end of the months blanking period to 12 months after ablation. [ Time Frame: 12 months after ablation ]
    AF recurrences will be documented by implantable loop recorder or trns-telephonic ECG recording


Secondary Outcome Measures :
  1. Identification of electrophysiological substrate [ Time Frame: during the procedure ]
    Areas with fast but regular activities or with consistent wave front propagation pattern, or with low P-P voltage, or complex fractionated electrograms

  2. inducibility of AF after the procedure [ Time Frame: during the procedure ]
    programmed atrial stimulation before and after isoproterenol

  3. AF burden [ Time Frame: 12 months after ablation ]
    Assessment of AF burden by trans-telephonic ECG recording or implantable loop recorder



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of 181 subjects suffering from persistent Atrial Fibrillation will be enrolled. Subject screening and enrollment will be carried out for approximately 12 months. A subject, who mets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in this study. All patients will be accounted for and documented, assigning an identification code linked to their names, alternative identification, or contact information.This log will be kept up to date throughout the clinical study by the principal investigator. To ensure subject privacy and confidentiality of data this log must be maintained throughout the clinical study at the clinical site.
Criteria

Inclusion Criteria: Age (18-85 years), persistent AF according to ESC/EHRA guidelines, first or second ablation procedure, ability to provide informed written consent.

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Exclusion Criteria: Secondary AF, Hyperthyroidism, LVEF<30%, NYHA functional class IV, uncorrected valvular heart diseases, contraindication to anticoagulation, left atrial thrombus, recent (<6 months) myocardial infarction, thoracic surgery for congenital, valvular diseases, History of cerebrovascular events, pregnancy, cancer or other significant comorbidities.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085731


Contacts
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Contact: Carlo Pappone, MD +39 02 52774260 carlo.pappone@af-ablation.org
Contact: Carlo Pappone, MD +39 02 527742282 carlo.pappone@af-ablation.org

Locations
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Italy
IRCCS Policlinico S. Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Carlo Pappone, MD, PhD    00390252774260    carlo.pappone@af-ablation.org   
Contact: Carlo Pappone, MD    00390252774260    carlo.pappone@af-ablation.org   
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Carlo Pappone, MD IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

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Responsible Party: Carlo Pappone, Director, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT04085731     History of Changes
Other Study ID Numbers: Persistent AF Ablation
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes