RECRUITING

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

Conditions

Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation Long-standing Persistent Atrial Fibrillation Atrial Fibrillation A-Fib Treatment of Atrial Fibrillation A-Fib Ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Official Title

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

Quick Facts

Study Start:2025-04-15

Study Completion:2027-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06765356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 or older * Diagnosed with atrial fibrillation with or without concomitant atrial flutter by ECG at some point in the past, and by any criteria (ECG or clear symptoms within the past year) * Previous catheter ablation for other arrhythmias (including left-sided ablation, but not for AF) is allowed * Planned for a clinically-indicated catheter ablation procedure for managing paroxysmal or persistent atrial fibrillation in accordance with the following recommendations in the ACC/AHA/ACCP/HRS guidelines * In patients with symptomatic AF in whom antiarrhythmic drugs have been ineffective, contraindicated, not tolerated or not preferred, and continued rhythm control is desired, catheter ablation is useful to improve symptoms.(Class 1) * In selected patients (generally younger with few comorbidities) with symptomatic paroxysmal AF in whom rhythm control is desired, catheter ablation is useful as first-line therapy to improve symptoms and reduce progression to persistent AF. (Class 1) * In patients (other than younger with few comorbidities) with symptomatic paroxysmal or persistent AF who are being managed with a rhythm-control strategy, catheter ablation as first-line therapy can be useful to improve symptoms. (Class 2a) * In selected patients with asymptomatic or minimally symptomatic AF, catheter ablation may be useful for reducing progression of AF and its associated complications. (Class 2b) * In patients who present with a new diagnosis of HFrEF and AF, arrhythmia-induced cardiomyopathy should be suspected, and an early and aggressive approach to AF rhythm control is recommended. (Class 1) * In appropriate patients with AF and HFrEF who are on GDMT, and with reasonable expectation of procedural benefit, catheter ablation is beneficial to improve symptoms, QOL, ventricular function, and cardiovascular outcomes. (Class 1) * In appropriate patients with symptomatic AF and HFpEF with reasonable expectation of benefit, catheter ablation can be useful to improve symptoms and improve QOL. (Class 2a) * In athletes who develop AF, catheter ablation with PVI is a reasonable strategy for rhythm control because of its effectiveness and low risk of detrimental effect on exercise capacity. (Class 2a) * Have in place or have plans for implantation of a loop recorder, pacemaker or cardiac defibrillator capable of recording atrial rhythm (e.g. dual chamber) (ideally, this implantable device would be present for at least 4 weeks pre-PFA) * Able and willing to provide written consent and comply with all testing and follow-up requirements	* Documented "active" left atrial thrombus (patients may later undergo the procedure if this is no longer present, eg, with anticoagulation treatment) * Reversible cause of AF (e.g., post-operative, thyroid disorder, etc.) * Conditions that make an AF ablation procedure unlikely to be successful (e.g., advanced infiltrative cardiomyopathies like amyloid, severe mitral stenosis or regurgitation, and cor pulmonale) * PCI/STEMI within the prior 1 month * Active systemic infection or sepsis * Contraindication to all anticoagulation * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial. * Life expectancy or other disease processes likely to limit survival to less than 12 months * Currently, enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.

Inclusion Criteria

Exclusion Criteria

* Age 18 or older
* Diagnosed with atrial fibrillation with or without concomitant atrial flutter by ECG at some point in the past, and by any criteria (ECG or clear symptoms within the past year)
* Previous catheter ablation for other arrhythmias (including left-sided ablation, but not for AF) is allowed
* Planned for a clinically-indicated catheter ablation procedure for managing paroxysmal or persistent atrial fibrillation in accordance with the following recommendations in the ACC/AHA/ACCP/HRS guidelines
* In patients with symptomatic AF in whom antiarrhythmic drugs have been ineffective, contraindicated, not tolerated or not preferred, and continued rhythm control is desired, catheter ablation is useful to improve symptoms.(Class 1)
* In selected patients (generally younger with few comorbidities) with symptomatic paroxysmal AF in whom rhythm control is desired, catheter ablation is useful as first-line therapy to improve symptoms and reduce progression to persistent AF. (Class 1)
* In patients (other than younger with few comorbidities) with symptomatic paroxysmal or persistent AF who are being managed with a rhythm-control strategy, catheter ablation as first-line therapy can be useful to improve symptoms. (Class 2a)
* In selected patients with asymptomatic or minimally symptomatic AF, catheter ablation may be useful for reducing progression of AF and its associated complications. (Class 2b)
* In patients who present with a new diagnosis of HFrEF and AF, arrhythmia-induced cardiomyopathy should be suspected, and an early and aggressive approach to AF rhythm control is recommended. (Class 1)
* In appropriate patients with AF and HFrEF who are on GDMT, and with reasonable expectation of procedural benefit, catheter ablation is beneficial to improve symptoms, QOL, ventricular function, and cardiovascular outcomes. (Class 1)
* In appropriate patients with symptomatic AF and HFpEF with reasonable expectation of benefit, catheter ablation can be useful to improve symptoms and improve QOL. (Class 2a)
* In athletes who develop AF, catheter ablation with PVI is a reasonable strategy for rhythm control because of its effectiveness and low risk of detrimental effect on exercise capacity. (Class 2a)
* Have in place or have plans for implantation of a loop recorder, pacemaker or cardiac defibrillator capable of recording atrial rhythm (e.g. dual chamber) (ideally, this implantable device would be present for at least 4 weeks pre-PFA)
* Able and willing to provide written consent and comply with all testing and follow-up requirements

* Documented "active" left atrial thrombus (patients may later undergo the procedure if this is no longer present, eg, with anticoagulation treatment)
* Reversible cause of AF (e.g., post-operative, thyroid disorder, etc.)
* Conditions that make an AF ablation procedure unlikely to be successful (e.g., advanced infiltrative cardiomyopathies like amyloid, severe mitral stenosis or regurgitation, and cor pulmonale)
* PCI/STEMI within the prior 1 month
* Active systemic infection or sepsis
* Contraindication to all anticoagulation
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
* Life expectancy or other disease processes likely to limit survival to less than 12 months
* Currently, enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.

Contacts and Locations

Study Contact

Jerome A Tonog, MD

CONTACT

2122415214

jerome.tonog@mountsinai.org

Betsy A Ellsworth, MSN, ANP

CONTACT

Betsy.ellsworth@mountsinai.org

Principal Investigator

Vivek Reddy, MD

PRINCIPAL_INVESTIGATOR

The Mount Sinai Hospital, Icahn School of Medicine

Study Locations (Sites)

The Mount Sinai Hospital

New York, New York, 10029

United States

Trident Medical Center

North Charleston, South Carolina, 29406

United States

Collaborators and Investigators

Sponsor: Vivek Reddy

Vivek Reddy, MD, PRINCIPAL_INVESTIGATOR, The Mount Sinai Hospital, Icahn School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15

Study Completion Date2027-03-30

Study Record Updates

Study Start Date2025-04-15

Study Completion Date2027-03-30

Terms related to this study

Keywords Provided by Researchers

Atrial Fibrillation
A-Fib
Treatment of Atrial Fibrillation
A-Fib Ablation

Additional Relevant MeSH Terms

Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Long-standing Persistent Atrial Fibrillation