An observational study in Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation. Completed at 26 sites in 6 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Boston Scientific Corporation · Observational
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 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:
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 415 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects included in the INTERRUPT AF study should be selected from the investigator's general patient population indicated for catheter ablation of PAF.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Time frame: 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
Time frame: 12 Months
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
Time frame: 12 Months
| Milestone | INTERRUPT AF Clinical Study |
|---|---|
| Started | 415 |
| Procedure | 383 |
| Completed | 148 |
| Not completed | 267 |
| Withdrew: Active at study close | 136 |
| Withdrew: Subject withdrew consent | 40 |
| Withdrew: Intent | 32 |
| Withdrew: Lost to follow-up | 31 |
| Withdrew: Research facility closed down | 9 |
| Withdrew: Death | 5 |
| Withdrew: Physician decision | 4 |
| Withdrew: No longer meets protocol criteria | 3 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Sponsor withdrew subject | 1 |
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 | Treatment With Ablation Catheter |
|---|---|
| Number of Participants Safety Event-free at 12 Months Post Procedure | 368 |
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
| Number of Participants | Treatment With Ablation Catheter |
|---|---|
| Number of Participants Effectiveness Event -Free at 12 Months Post Procedure | 218 |
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
| Participants | Treatment With Ablation Catheter |
|---|---|
| Number of Participants Event Free Rate (Secondary) | 102 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Ablation Catheter | 5/383 (1.3%) | 135/383 (35.2%) | 46/383 (12%) |
| Event | Treatment With Ablation Catheter |
|---|---|
| Atrial FibrillationCardiac disorders | 46/383 |
| Atrial FlutterCardiac disorders | 12/383 |
| GastrointestinalGastrointestinal disorders | 11/383 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 11/383 |
| Angina/Chest painSurgical and medical procedures | 7/383 |
| Physical traumaGeneral disorders | 7/383 |
| Abnormal laboratory valuesGeneral disorders | 6/383 |
| Chest pain - OtherGeneral disorders | 6/383 |
| Pericardial effusion - EP procedureInjury, poisoning and procedural complications | 6/383 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 6/383 |
| Event | Treatment With Ablation Catheter |
|---|---|
| Angina/Chest pain - Post EP procedureInjury, poisoning and procedural complications | 8/383 |
| Post-surgical wound discomfort - EP procedureInjury, poisoning and procedural complications | 6/383 |
| Atrial Fibrillation (AF)Cardiac disorders | 5/383 |
| Pain (non-cardiovascular) - EP procedureInjury, poisoning and procedural complications | 5/383 |
| Minor oozing/bleeding - EP procedureInjury, poisoning and procedural complications | 3/383 |
| Ablation-EP Related~OtherInjury, poisoning and procedural complications | 3/383 |
| Atrial Flutter, not specifiedCardiac disorders | 2/383 |
| Adverse reaction - Genitourinary/Renal - EP procedureInjury, poisoning and procedural complications | 2/383 |
| Adverse reaction - Neurological (non-TIA, non-stroke) - EP procedureInjury, poisoning and procedural complications | 2/383 |
| Hematoma - EP procedureInjury, poisoning and procedural complications | 2/383 |
| Age, Continuous(years) | INTERRUPT AF Clinical Study |
|---|---|
| Mean | 63.2 ± 10.4 |
| Sex: Female, Male(Participants) | INTERRUPT AF Clinical Study |
|---|---|
| Female | 155 |
| Male | 259 |
| Race/Ethnicity, Customized(Participants) | INTERRUPT AF Clinical Study |
|---|---|
| Race — White | 282 |
| Race — Black | 10 |
| Race — Hispanic or Latino | 5 |
| Race — Asian | 95 |
| Race — Race Not Disclosed | 15 |
| Region of Enrollment(participants) | INTERRUPT AF Clinical Study |
|---|---|
| South Korea | 21 |
| Monaco | 6 |
| United States | 278 |
| Japan | 82 |
| United Kingdom | 4 |
| Germany | 24 |
| Weight(kg) | INTERRUPT AF Clinical Study |
|---|---|
| Mean | 87.7 ± 24.2 |
| Height(cm) | INTERRUPT AF Clinical Study |
|---|---|
| Mean | 172.1 ± 10.2 |
| BMI(kg/m^2) | INTERRUPT AF Clinical Study |
|---|---|
| Mean | 29.4 ± 7.2 |
| Resting Systolic BP(mmHG) | INTERRUPT AF Clinical Study |
|---|---|
| Mean | 132.6 ± 19.6 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Ran from Mar 2019 to primary completion in May 2024, 61 months.
Results were first posted in Jan 2026, 1 year 8 months after primary completion.
Of 148 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's 61 months is above that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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