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

• ClinicalTrials.gov Identifier: NCT04702451
• Recruitment Status: Completed
• First Posted: January 8, 2021
• Last Update Posted: April 23, 2024
• Sponsor: Volta Medical
• Collaborators: Covance; CardiaBase
• Information provided by (Responsible Party): Volta Medical

Tracking Information

• First Submitted Date: January 7, 2021
• First Posted Date: January 8, 2021
• Last Update Posted Date: April 23, 2024
• Actual Study Start Date: February 12, 2021
• Actual Primary Completion Date: December 27, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2021)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2022)

• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: January 7, 2021)

• 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 index ablation procedure
• Freedom from documented AF/AT after one or more ablation procedure(s) [ Time Frame: 12 months ]
  Freedom from documented AF/AT episodes > 30 seconds, after one procedure or more, with or without AADs, at 12 months
• Freedom from documented AF after one or more ablation procedure(s) [ Time Frame: 12 months ]
  Freedom from documented AF episodes > 30 seconds, after one procedure or more, with or without AADs, at 12 months
• Safety endpoint [ Time Frame: 12 months ]
  Safety composite endpoint at 12 months: death, cerebrovascular events, or serious treatment-related adverse event

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
• Official Title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Controlled Trial

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Atrial Fibrillation

Intervention

• Procedure: Dispersion ablation + PVI
  Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
• Device: VX1
  VX1-based dispersion mapping
• Procedure: PVI
  Pulmonary vein antrum isolation

Study Arms

• Experimental: Tailored
  Tailored ablation strategy
  Interventions:

  • Procedure: Dispersion ablation + PVI
  • Device: VX1
• Active Comparator: Anatomical
  Anatomical ablation strategy
  Intervention: Procedure: PVI

Publications *

• Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.
• Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 8, 2023): 377
• Original Estimated Enrollment (submitted: January 7, 2021): 344
• Actual Study Completion Date: December 27, 2023
• Actual Primary Completion Date: December 27, 2023 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany, Netherlands, United States

Administrative Information

• NCT Number: NCT04702451
• Other Study ID Numbers: CLIPL-01-002
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Volta Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Volta Medical
• Original Study Sponsor: Same as current

Collaborators

• Covance
• CardiaBase

Investigators

• Study Chair: Isabel Deisenhofer, MD; Deutsches Herzzentrum Muenchen

• PRS Account: Volta Medical
• Verification Date: April 2024