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

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ClinicalTrials.gov Identifier: NCT03729830
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date November 1, 2018
First Posted Date November 5, 2018
Last Update Posted Date September 9, 2021
Actual Study Start Date March 4, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2020)
  • Safety event-free rate [ Time Frame: 12 months ]
    The primary safety endpoint is defined as the safety event-free rate at 12 months post-procedure. Primary safety events will consist of 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).
  • Event Free Rate (Primary) [ 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
Original Primary Outcome Measures
 (submitted: November 1, 2018)
  • Safety event-free rate [ Time Frame: 12 months ]
    The primary safety endpoint is defined as the safety event-free rate at 12 months post-procedure. Primary safety events will consist of 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).
  • Event Free Rate (Primary) [ 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*
Change History
Current Secondary Outcome Measures
 (submitted: November 18, 2020)
Event Free Rate (Secondary) [ Time Frame: 12 Months ]
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
Original Secondary Outcome Measures
 (submitted: November 1, 2018)
Event Free Rate (Secondary) [ Time Frame: 12 Months ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
Official Title Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
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).

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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Paroxysmal Atrial Fibrillation
Intervention Device: Boston Scientific Open Irrigated Ablation Catheters
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2018)
415
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2024
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rami Guirguis 919-374-3388 rami.guirguis@bsci.com
Contact: Sarfaraz Taher 651-582 5320 Sarfaraz.Taher@bsci.com
Listed Location Countries Germany,   Japan,   Korea, Republic of,   Monaco,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03729830
Other Study ID Numbers 92249986
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
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
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Oussama Wazni The Cleveland Clinic
PRS Account Boston Scientific Corporation
Verification Date October 2020