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Paroxysmal Atrial FibrillationADVENTNCT04612244

The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

A study testing FARAPULSE Pulsed Field Ablation System and RadioFrequency and Cryoballoon Ablation in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
FARAPULSE Pulsed Field Ablation System and RadioFrequency and Cryoballoon Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
706 participants
Where
34 sitesUnited States
Study dates
1 Mar 2021to 15 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:
  • 1. AF that is any of the following:
  • <!-- -->
  • Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days
  • Requires four (4) or more direct-current cardioversions in the preceding 12 months
  • Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes
Show all 78Show fewer
  • 2. Any of the following atrial conditions:
  • Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
  • Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
  • Any prior atrial surgery
  • Intra-atrial septal patch or interatrial shunt
  • Atrial myxoma
  • Current LA thrombus
  • LA appendage closure, device or occlusion, past or anticipated
  • Any PV abnormality, stenosis or stenting (common and middle PVs are admissible)
  • 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:
  • Sustained ventricular tachycardia or any ventricular fibrillation
  • Hemodynamically significant valvular disease:
  • Valvular disease that is symptomatic
  • Valvular disease causing or exacerbating congestive heart failure
  • Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20 mm Hg
  • Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg
  • Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements
  • Hypertrophic cardiomyopathy
  • Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
  • Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
  • Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access
  • History of rheumatic fever
  • History of congenital heart disease with any residual anatomic or conduction abnormality
  • 4. Any of the following procedures, implants or conditions:
  • At baseline:
  • New York Heart Association (NYHA) Class III/IV
  • Left ventricular ejection fraction (LVEF) < 40%
  • Symptomatic hypotension
  • Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment)
  • Symptomatic resting bradycardia
  • Implantable loop recorder or insertable cardiac monitor,
  • Within the 3 months preceding the Consent Date:
  • Myocardial infarction
  • Unstable angina
  • Percutaneous coronary intervention
  • Heart failure hospitalization
  • Treatment with amiodarone
  • Pericarditis or symptomatic pericardial effusion
  • Gastrointestinal bleeding
  • Within the 6 months preceding the Consent Date:
  • Heart surgery
  • Stroke, TIA or intracranial bleeding
  • Any thromboembolic event
  • Carotid stenting or endarterectomy
  • 5. Diagnosed disorder of blood clotting or bleeding diathesis
  • 6. Contraindication to, or unwillingness to use, systemic anticoagulation
  • 7. Patient who is not on anticoagulation therapy for at least 3 weeks prior to the ablation procedure
  • 8. Contraindication to both CT and MRI
  • 9. Sensitivity to contrast media not controllable by premedication
  • 10. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period
  • 11. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
  • Body Mass Index (BMI) > 40.0
  • Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
  • Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
  • Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
  • Active systemic infection
  • COVID-19 disease
  • Current confirmed, active COVID-19 disease
  • Current positive test for SARS-CoV-2
  • Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date.
  • Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained) or active alcohol abuse
  • Sleep apnea and:
  • An apnea-hypopnea index (AHI) ≥ 15, or
  • An AHI of ≥ 5 and ≤14 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke, unless compliant with continuous positive airway pressure (CPAP) treatment.
  • Predicted life expectancy less than one (1) year
  • 12. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements
  • 13. Current or anticipated enrollment in any other randomized, interventional or Food and Drug Administration (FDA)-regulated clinical study (data collection for registries or retrospective studies is permitted)
  • 14. Employees / family members of:
  • FARAPULSE or any of its affiliates or contractors
  • The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • St Davids_Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • St Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Center/Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Saint Thomas Heart at Baptist Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • NYU Langone Health_Heart Rhythm Center

    New York, New York, 10016

  • Mount Sinai, Icahn School of Medicine

    New York, New York, 10029

  • Northwell Health- Lenox Hill Hospital

    New York, New York, 10075

  • MedStar Washington Hospital Center

    Northwest, Washington, 20010

  • Nebraska Methodist Health system, Inc

    Omaha, Nebraska, 68114

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center

    Phoenix, Arizona, 85006

  • Providence St Vincent Medical Center, Heart and Vascular Clinical Trials

    Portland, Oregon, 97225

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23298

  • California Pacific Medical Center

    San Francisco, California, 94109

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • HonorHealth Scottsdale Shea

    Scottsdale, Arizona, 85258

  • Swedish Medical Center Heart & Vascular Research

    Seattle, Washington, 98122

  • UPMC Pinnacle Health Cardiovascular Institute Inc.

    Wormleysburg, Pennsylvania, 17105

Other trials in United States

About this study

Official title: A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation

This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.

Being tested
FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FARAPULSE Pulsed Field Ablation SystemDevice

    Ablation using the FARAPULSE Pulsed Field Ablation System

  • RadioFrequency and Cryoballoon AblationDevice

    Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation

Study groups in NCT04612244
Study groupRoleWhat they receive
FARAPULSE Pulsed Field Ablation SystemExperimentalNot described
Receives: Device: FARAPULSE Pulsed Field Ablation System
Force Sensing Radiofrequency Ablation and Cryoballoon AblationActive comparatorNot described
Receives: Device: RadioFrequency and Cryoballoon Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs

    Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs

    Measured: 7 days and 12 Months

  2. Primary Effectiveness Endpoint

    Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as:

    1. Acute Procedural Success AND
    2. Chronic Success, defined as freedom from:
    3. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI
    4. After the Blanking Period:
    5. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study) ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter) iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT
    6. At any time:
    7. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter) ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).

    Measured: 12-Months

Secondary outcomes (2)

  1. Change in PV Cross-sectional Area

    Mean change in aggregate PV Cross-Sectional area (cm^2) from baseline to Day 90

    Measured: 3 months

  2. Primary Effectiveness Treatment Success Tested for Superiority

    The secondary effectiveness endpoint is the same as the primary effectiveness endpoint but will be tested for superiority rather than non-inferiority. The proportion of Pulsed Field Subjects with Treatment Success will be assessed for superiority to the proportion of Thermal Subjects with Treatment Success.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2020
  2. Study start1 Mar 2021
  3. Primary completion15 May 2023
  4. Study completion15 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
706 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04612244
Sponsor's protocol ID
CS0934
Acronym
ADVENT
Status last verified
Nov 2024
First submitted
26 Oct 2020
Last updated
20 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gerstenfeld EP, Mansour M, Whang W, Venkateswaran R, Harding JD, Ellis CR, Ellenbogen KA, Osorio J, DeLurgio DB, Daccarett M, Mangrum M, McElderry T, Richards E, Albrecht EM, Schneider CW, Sutton BS, Reddy VY. Autonomic Effects of Pulsed Field vs Thermal Ablation for Treating Atrial Fibrillation: Subanalysis of ADVENT. JACC Clin Electrophysiol. 2024 Jul;10(7 Pt 2):1634-1644. doi: 10.1016/j.jacep.2024.05.005. Epub 2024 May 16.

    PubMed 38869507

  • Reddy VY, Mansour M, Calkins H, d'Avila A, Chinitz L, Woods C, Gupta SK, Kim J, Eldadah ZA, Pickett RA, Winterfield J, Su WW, Waks JW, Schneider CW, Richards E, Albrecht EM, Sutton BS, Gerstenfeld EP; ADVENT Investigators. Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. 2024 Jul 2;84(1):61-74. doi: 10.1016/j.jacc.2024.05.001. Epub 2024 May 18.

    PubMed 38864538

  • Patel C, Gerstenfeld EP, Gupta SK, Winterfield J, Woods C, Natale A, Schneider CW, Achyutha AB, Holland SK, Richards E, Albrecht EM, Lehmann JW, Mansour M, Reddy VY. Comparison of cerebral safety after atrial fibrillation using pulsed field and thermal ablation: Results of the neurological assessment subgroup in the ADVENT trial. Heart Rhythm. 2024 Nov;21(11):2103-2109. doi: 10.1016/j.hrthm.2024.05.048. Epub 2024 May 31.

    PubMed 38823667

  • Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, Mountantonakis SE, Gibson DN, Harding JD, Ellis CR, Ellenbogen KA, DeLurgio DB, Osorio J, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Mansour M; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291. Epub 2023 Aug 27.

    PubMed 37634148

Questions about this trial

What is this clinical trial studying?

A study testing FARAPULSE Pulsed Field Ablation System and RadioFrequency and Cryoballoon Ablation in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 78 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs (time frame: 7 days and 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04612244, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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