Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

Completed

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).

Key facts

Study ID

NCT03729830

Run by

Boston Scientific Corporation

People needed

415

Starts

2019-03-04

Expected to finish

2024-05-03

Last updated by the study team

2026-01-21

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment.
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
• Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law.

You may not qualify if…

• Subjects enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
• Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study
• Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
• Subjects who have undergone any cardiac ablation within 30 days prior to enrollment
• Unrecovered/unresolved Adverse Events from any previous invasive procedure
• Life expectancy <= three years per physician opinion
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
• Known cardiac thrombus within 60 days prior to enrollment
• History of CVA, TIA or PE within 90 days prior to enrollment
• Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment
• Implanted Left atrial appendage closure device prior to the index procedure
• Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair)
• Left atrial diameter greater than 5.5cm
• Documented or suspected stenosis of any pulmonary veins.
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Contraindication for anticoagulation
• Clinically significant mitral valve regurgitation or stenosis per investigator discretion.
• Any cardiac surgery ≤ 90 days from consent date.
• Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Broward General Medical Center — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• St. Lukes Idaho Cardiology Associates — Boise, Idaho, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Kaleida Health — Buffalo, New York, United States
• Bethesda North Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• HeartPlace Mid-Cities EP — Bedford, Texas, United States
• Orion Medical — Pasadena, Texas, United States
• Christus Trinity Mother Frances Health System — Tyler, Texas, United States
• Staedtisches Klinikum Karlsruhe — Karlsruhe, Germany
• Juedisches Krankenhaus Berlin — Mitte, Germany
• Kokura Memorial Hospital — Fukuoka-ken, Japan
• Yokosuka Kyosai Hospital — Kanagawa Prefecture, Japan
• Centre Hospitalier Princesse Grace — Monaco, Monaco
• Keimyung University Dongsan Medical Center — Daegu, South Korea
• Korea University Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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