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

NCT03729830 | Completed Results FDA Device

• 1 other identifier: 92249986
• Study Type: observational
• Target: 415
• Locations: 6 countries
• Sites: 26

Brief Summary

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).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants Safety Event-free at 12 Months Post Procedure

  This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following: * Death * Myocardial infarction (MI) * Vagal Nerve Injury/Gastroparesis * Transient ischemic attack (TIA) * Stroke/Cerebrovascular accident (CVA) * Thromboembolism * Pericarditis * Cardiac tamponade/perforation * Pneumothorax * Vascular access complications * Pulmonary edema/heart failure * AV block Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure * Atrial esophageal fistula * Pericardial effusion * Pulmonary vein stenosis (symptomatic and requiring intervention)

  12 months

• Number of Participants Effectiveness Event -Free at 12 Months Post Procedure

  The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as: * Acute procedural failure * More than one repeat procedure during the blanking period (90 days post index procedure) * Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration from an event monitor or Holter, or from a 10 second 12-lead EKG) between 91 days and 365 days post index procedure * Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between 91 days and 365 days post index procedure: * Repeat procedure * Cardioversion * Prescribed any AAD\* * AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence

  12 Months

Secondary Outcomes (1)

• Number of Participants Event Free Rate (Secondary)

  12 Months

Interventions

Boston Scientific Open Irrigated Ablation Catheters DEVICE

The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects included in the INTERRUPT AF study should be selected from the investigator's general patient population indicated for catheter ablation of PAF.

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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (26)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Broward General Medical Center

Miami, Florida, 33136, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

St. Lukes Idaho Cardiology Associates

Boise, Idaho, 83712, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756-1000, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Kaleida Health

Buffalo, New York, 14213, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

HeartPlace Mid-Cities EP

Bedford, Texas, 76021, United States

Location

Orion Medical

Pasadena, Texas, 77505, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Staedtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Juedisches Krankenhaus Berlin

Mitte, 13347, Germany

Location

Kokura Memorial Hospital

Fukuoka-ken, 802-8555, Japan

Location

Yokosuka Kyosai Hospital

Kanagawa Prefecture, 238-8558, Japan

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Korea University Medical Center

Seoul, 2841, South Korea

Location

Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Susan Hampson, Clinical Trial Manager
• Organization: Boston Scientific

susan.hampson@bsci.com

508-728-5165

Study Officials

• Oussama Wazni

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: March 4, 2019
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); MO (1); KR (2); GB (1); DE (2); US (18)