- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04085731
Driver-guided Ablation of Persistent Atrial Fibrillatiom
Driver-guided Ablation in the Treatment of Persistent Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlo Pappone, MD
- Phone Number: +39 02 527742282
- Email: carlo.pappone@af-ablation.org
Study Contact Backup
- Name: Carlo Pappone, MD
- Phone Number: +39 02 52774260
- Email: carlo.pappone@af-ablation.org
Study Locations
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Milano
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San Donato Milanese, Milano, Italy, 20097
- Recruiting
- IRCCS Policlinico S. Donato
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Contact:
- Carlo Pappone, MD, PhD
- Phone Number: 00390252774260
- Email: carlo.pappone@af-ablation.org
-
Contact:
- Carlo Pappone, MD
- Phone Number: 00390252774260
- Email: carlo.pappone@af-ablation.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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AF recurrences will be documented by implantable loop recorder or trns-telephonic ECG recording
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12 months after ablation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during the procedure
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inducibility of AF after the procedure
Time Frame: during the procedure
|
programmed atrial stimulation before and after isoproterenol
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during the procedure
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AF burden
Time Frame: 12 months after ablation
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Assessment of AF burden by trans-telephonic ECG recording or implantable loop recorder
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12 months after ablation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlo Pappone, MD, IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Persistent AF Ablation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Catheter ablation
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Emory UniversityBoston Scientific CorporationCompleted
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Field MedicalNot yet recruitingVentricular Tachycardia | Ventricular Arrythmia | Ventricular Tachyarrhythmia | PVC - Premature Ventricular Complex | PVC - Premature Ventricular ContractionCzechia
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Erasmus Medical CenterUnknownTachycardia, Supraventricular | Tachycardia; Paroxysmal, SupraventricularNetherlands
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