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Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (Tailored-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702451
Recruitment Status : Active, not recruiting
First Posted : January 8, 2021
Last Update Posted : February 13, 2023
Sponsor:
Collaborators:
Covance
CardiaBase
Information provided by (Responsible Party):
Volta Medical

Study Description
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Brief Summary:

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Dispersion ablation + PVI Device: VX1 Procedure: PVI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Actual Study Start Date : February 12, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tailored
Tailored ablation strategy
 Procedure: Dispersion ablation + PVI
Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation

Device: VX1
VX1-based dispersion mapping
Active Comparator: Anatomical
Anatomical ablation strategy
 Procedure: PVI
Pulmonary vein antrum isolation


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from documented AF after one ablation procedure [ Time Frame: 12 months ]
    Freedom from documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure


Secondary Outcome Measures :
  1. Freedom from documented AF/AT after one or two ablation procedures [ Time Frame: 12 months ]
    Freedom from documented AF/AT episodes > 30 seconds, after one or two procedures, with or without AADs, at 12 months

  2. Freedom from documented AF/AT after one ablation procedure [ Time Frame: 12 months ]
    Freedom from documented AF/AT episodes > 30 seconds, with or without AADs, 12 months after a single ablation procedure

  3. Incidence of complications (safety composite endpoint) [ Time Frame: 12 months ]
    Incidence of complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older candidates for a first AF ablation
  • Symptomatic AF, refractory to at least one antiarrhythmic medication
  • Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and < 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
  • Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial
  • At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months

Exclusion Criteria:

  • Paroxysmal and short-standing AF < 3 months
  • Long-standing persistent AF > 5 years (≥ 1 year in the United States)
  • ≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
  • Severe obesity (BMI > 40)
  • Very dilated Left Atrium (LA)(e.g. LA diameter > 60 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
  • Patients with AF secondary to an obvious reversible cause
  • Inadequate anticoagulation as defined in the inclusion criteria
  • LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
  • Contraindications to anticoagulation (heparin, warfarin or NOAC)
  • Patients who are or may potentially be pregnant
  • Previous surgical or catheter ablation for AF
  • Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  • Myocardial infarction within the past 2 months (60 days)
  • Previous atrioventricular valve surgery
  • History of blood clotting or bleeding abnormalities
  • Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
  • Rheumatic Heart Disease
  • Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  • Unstable angina within the past month
  • Acute illness or active systemic infection or sepsis
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Diagnosed atrial myxoma
  • Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  • Enrollment in an investigational study evaluating another device, biologic, or drug
  • Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  • Life expectancy or other disease processes likely to limit survival to less than 12 months
  • Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
Contacts and Locations
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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): NCT04702451


Locations
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Sponsors and Collaborators
Volta Medical
Covance
CardiaBase
Investigators
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Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum Muenchen
More Information
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Publications:

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Responsible Party: Volta Medical
ClinicalTrials.gov Identifier: NCT04702451    
Other Study ID Numbers: CLIPL-01-002
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Volta Medical:
Persistent Atrial Fibrillation
Catheter Ablation
Electrogram dispersion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes