Paroxysmal Atrial FibrillationINTERRUPT AFNCT03729830
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 26 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Boston Scientific Open Irrigated Ablation Catheters
- Type of treatment
- Medical device
- How many people
- 415 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 4 Mar 2019to 3 May 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States18 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
HeartPlace Mid-Cities EP
Bedford, Texas, 76021
University of Alabama at Birmingham
Birmingham, Alabama, 35294
St. Lukes Idaho Cardiology Associates
Boise, Idaho, 83712
Kaleida Health
Buffalo, New York, 14213
University of Chicago Hospital
Chicago, Illinois, 60637
Bethesda North Hospital
Cincinnati, Ohio, 45220
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-1000
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Catholic Medical Center
Manchester, New Hampshire, 03102
Broward General Medical Center
Miami, Florida, 33136
AdventHealth Orlando
Orlando, Florida, 32803
Orion Medical
Pasadena, Texas, 77505
St. John's Hospital
Springfield, Illinois, 62769
Torrance Memorial Medical Center
Torrance, California, 90505
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701
Germany2 sites
Staedtisches Klinikum Karlsruhe
Karlsruhe, 76133
Juedisches Krankenhaus Berlin
Mitte, 13347
Japan2 sites
Kokura Memorial Hospital
Fukuoka-ken, 802-8555
Yokosuka Kyosai Hospital
Kanagawa Prefecture, 238-8558
South Korea2 sites
Keimyung University Dongsan Medical Center
Daegu, 42601
Korea University Medical Center
Seoul, 2841
About this study
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).
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Boston Scientific Open Irrigated Ablation Catheters
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific Open Irrigated Ablation CathetersDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 12 Months
Secondary outcomes (1)
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 baseline
- AADs for endpoint will consist of all Class I/III and any Class II/IV medications taken for control of AF/AT/AFL recurrence
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start4 Mar 2019
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oussama Wazni, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729830
- Sponsor's protocol ID
- 92249986
- Acronym
- INTERRUPT AF
- Status last verified
- Dec 2025
- First submitted
- 1 Nov 2018
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03729830
- Acronym / sponsor ID
- INTERRUPT AF / 92249986
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boston Scientific Open Irrigated Ablation CathetersThe 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. | Device | – |
Primary outcome
Number of Participants Safety Event-free at 12 Months Post Procedure
Time frame: 12 months
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)
Number of Participants Effectiveness Event -Free at 12 Months Post Procedure
Time frame: 12 Months
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
1 secondary outcome
Number of Participants Event Free Rate (Secondary)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oussama Wazni principal investigator
The Cleveland Clinic
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation at 26 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Germany, Japan, South Korea, Monaco and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Safety Event-free at 12 Months Post Procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.