ACTIVE_NOT_RECRUITING

A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:

Conditions

Atrial Fibrillation (AF)Atrial Arrhythmia Paroxysmal AF Drug Refractory Paroxysmal Atrial Fibrillation Symptomatic, recurrent, drug refractory PAF Atrial Fibrillation Pulsed Field Ablation Radio Frequency PFA

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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 objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).

Official Title

Safety and Effectiveness of the TactiFlex SE Catheter and Volt Pulsed Field Ablation (PFA) Generator in Subjects With Paroxysmal Atrial Fibrillation

Quick Facts

Study Start:2024-11-22

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06676072

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
1. Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows: 1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND 2. One electrocardiographically documented PAF episode within 12 months prior to enrollment. 2. Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication 3. At least 18 years of age 4. Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements 5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.	1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration) 2. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days 3. Known presence of cardiac thrombus 4. Left atrial diameter (LAD) \> or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure 5. Left ventricular ejection fraction (LVEF) \< or equal to 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure 6. New York Heart Association (NYHA) class III or IV heart failure 7. Body mass index \> or equal to 40 kg/m2 8. Pregnant or nursing 9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure 10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 11. Stroke or TIA (transient ischemic attack) within the last 90 days 12. Heart disease in which corrective surgery is anticipated within 180 days after procedure 13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state 14. Contraindication to long-term anti-thromboembolic therapy 15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device) 18. Plans to have an LAA closure device implanted during the follow-up period 19. Presence of any condition that precludes appropriate vascular access 20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2) 21. Previous tricuspid or mitral valve replacement or repair 22. Patients with prosthetic valves 23. Patients with a myxoma 24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 25. Stent, constriction, or stenosis in a pulmonary vein 26. Rheumatic heart disease 27. Hypertrophic cardiomyopathy 28. Active systemic infection 29. Renal failure requiring dialysis 30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms 31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device. 32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor 33. Unlikely to survive the protocol follow up period of 12 months 34. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 35. Individuals without legal authority 36. Individuals unable to read or write

Inclusion Criteria

Exclusion Criteria

1. Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows:
1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
2. One electrocardiographically documented PAF episode within 12 months prior to enrollment.
2. Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
3. At least 18 years of age
4. Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and requirements
5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
2. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
3. Known presence of cardiac thrombus
4. Left atrial diameter (LAD) \> or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
5. Left ventricular ejection fraction (LVEF) \< or equal to 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure
6. New York Heart Association (NYHA) class III or IV heart failure
7. Body mass index \> or equal to 40 kg/m2
8. Pregnant or nursing
9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure
10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
11. Stroke or TIA (transient ischemic attack) within the last 90 days
12. Heart disease in which corrective surgery is anticipated within 180 days after procedure
13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state
14. Contraindication to long-term anti-thromboembolic therapy
15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
18. Plans to have an LAA closure device implanted during the follow-up period
19. Presence of any condition that precludes appropriate vascular access
20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
21. Previous tricuspid or mitral valve replacement or repair
22. Patients with prosthetic valves
23. Patients with a myxoma
24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
25. Stent, constriction, or stenosis in a pulmonary vein
26. Rheumatic heart disease
27. Hypertrophic cardiomyopathy
28. Active systemic infection
29. Renal failure requiring dialysis
30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.
32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor
33. Unlikely to survive the protocol follow up period of 12 months
34. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
35. Individuals without legal authority
36. Individuals unable to read or write

Contacts and Locations

Principal Investigator

Sarah Kammer

STUDY_DIRECTOR

Abbott Medical Devices

Study Locations (Sites)

HonorHealth

Scottsdale, Arizona, 85258

United States

Arkansas Heart Hospital

Little Rock, Arkansas, 72211

United States

Stanford University Medical Center

Stanford, California, 94305

United States

South Denver Cardiology Associates PC

Littleton, Colorado, 80120

United States

HCA Florida Mercy Hospital

Miami, Florida, 33133

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Tallahassee Research Institute

Tallahassee, Florida, 32308

United States

Piedmont Athens Regional Medical Center

Athens, Georgia, 30606

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Michigan Medical Center

Ann Arbor, Michigan, 48104

United States

Henry Ford Providence Southfield Hospital

Southfield, Michigan, 48075

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

The Heart Rhythm Center of MS

Gulfport, Mississippi, 39501

United States

Bryan Heart Medical Center

Lincoln, Nebraska, 68506

United States

NYU Langone Health

New York, New York, 10016

United States

New York Presbyterian Hospital/Cornell University

New York, New York, 10021

United States

Duke University Medical Center

Durham, North Carolina, 27705

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Tristar Centennial Medical Center

Nashville, Tennessee, 37203

United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232

United States

Texas Cardiac Arrhythmia

Austin, Texas, 78705

United States

Ocelot Medical Research Group

Dallas, Texas, 75230

United States

Medical City Fort Worth

Fort Worth, Texas, 76104

United States

Houston Methodist The Woodlands Hospital

Shenandoah, Texas, 77385

United States

Virginia Commonwealth University

Richmond, Virginia, 23219

United States

The Heart Institute at Virginia Mason

Seattle, Washington, 98111

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Sarah Kammer, STUDY_DIRECTOR, Abbott Medical Devices

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 Date2024-11-22

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-11-22

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Symptomatic, recurrent, drug refractory PAF
Atrial Fibrillation
Paroxysmal AF
Pulsed Field Ablation
Radio Frequency
PFA

Additional Relevant MeSH Terms

Atrial Fibrillation (AF)
Atrial Arrhythmia
Paroxysmal AF
Drug Refractory Paroxysmal Atrial Fibrillation