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

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).

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Boston Scientific Open Irrigated Ablation Catheters

Detailed Description

STUDY OBJECTIVE(S) -- 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).

INDICATION(S) FOR USE -- Study devices will be used per approved Indications for Use for each geography.

DEVICES / SYSTEM USED IN THE STUDY -- The study will include the following Boston Scientific Open-Irrigated Catheters in geographies where commercially approved for PAF ablation:

• Blazer Open-Irrigated Ablation Catheter
• IntellaNav Open-Irrigated Ablation Catheter
• IntellaNav MiFi Open-Irrigated Ablation Catheter
• IntellaTip MiFi Open-Irrigated Ablation Catheter
• Rhythmia Mapping System Gen 1or Rhythmia HDx, equipped with Software 1.4 or any successive commercially approved versions.
• IntellaMap Orion Catheter

CONTROL DEVICE -- There are no control devices in this study

STUDY DESIGN -- Prospective, non-randomized, multicenter (global), post approval clinical study (PAS). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for three years to complete the PAS design mandated from the FDA to collect post-market data for Boston Scientific Open-Irrigated Catheters and will be followed for three years.

PLANNED NUMBER OF SUBJECTS -- The study will enroll 415 subjects.

PLANNED NUMBER OF SITES / COUNTRIES -- The study is global (US, EU, Asia-Pacific) with 25-50 centers. A minimum of 50% of the sites will be selected from the US. No study site will be allowed to contribute more than 41 subjects (10% of the 415 enrollments requirement).

FOLLOW-UP SCHEDULE -- Study Follow-ups are at: pre-discharge, 1 month (phone check), 3 months (blanking period), 6 months (phone check), 12 months, 24 months and 36 months.

STUDY DURATION -- Study is expected to be completed in approximately five years (12-24 month enrollment period with three year follow-up).

PARTICIPANT DURATION -- The study duration for each subject is expected to be approximately three years.

• Study Type: Observational
• Enrollment (Actual): 415

Contacts and Locations

Study Locations

• Germany
  • Karlsruhe, Germany, 76133
    • Staedtisches Klinikum Karlsruhe
  • Mitte, Germany, 13347
    • Juedisches Krankenhaus Berlin
• Japan
  • Fukuoka-ken, Japan, 802-8555
    • Kokura Memorial Hospital
  • Kanagawa Prefecture, Japan, 238-8558
    • Yokosuka Kyosai Hospital
• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace
• South Korea
  • Daegu, South Korea, 42601
    • Keimyung University Dongsan Medical Center
  • Seoul, South Korea, 2841
    • Korea University Medical Center
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Papworth Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Florida
    • Miami, Florida, United States, 33136
      • Broward General Medical Center
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Lukes Idaho Cardiology Associates
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-1000
      • Dartmouth Hitchcock Medical Center
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New York
    • Buffalo, New York, United States, 14213
      • Kaleida Health
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Bethesda North Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
  • Texas
    • Bedford, Texas, United States, 76021
      • HeartPlace Mid-Cities EP
    • Pasadena, Texas, United States, 77505
      • Orion Medical
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. 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.
2. Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines
3. 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
4. Subjects who are willing and capable of providing informed consent
5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
6. Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. 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
2. Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study
3. Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
4. Subjects who have undergone any cardiac ablation within 30 days prior to enrollment
5. Unrecovered/unresolved Adverse Events from any previous invasive procedure
6. Life expectancy <= three years per physician opinion
7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
8. Known cardiac thrombus within 60 days prior to enrollment
9. History of CVA, TIA or PE within 90 days prior to enrollment
10. Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment
11. Implanted Left atrial appendage closure device prior to the index procedure
12. Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair)
13. Left atrial diameter greater than 5.5cm
14. Documented or suspected stenosis of any pulmonary veins.
15. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
16. Contraindication for anticoagulation
17. Clinically significant mitral valve regurgitation or stenosis per investigator discretion.
18. Any cardiac surgery ≤ 90 days from consent date.
19. Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Event Free Rate (Secondary)	The secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure. Secondary effectiveness events are defined as: Acute procedural failure; More than one repeat procedure during the blanking period (90 days post index procedure); Documented symptomatic 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 a higher dose of any AAD* documented at baseline; Prescribed a new AAD* not documented at baselineAADs 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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Oussama Wazni, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 92249986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes