Clinical trial NCT03729830: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-05
Enrollment: 415
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Safety event-free rate
timeFrame: 12 months
measure: Event Free Rate (Primary)
timeFrame: 12 Months
Secondary outcomes:
measure: Event Free Rate (Secondary)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Miami
country: United States
facility: Broward General Medical Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Boise
country: United States
facility: St. Lukes Idaho Cardiology Associates
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bedford
country: United States
facility: HeartPlace Mid-Cities EP
state: Texas
city: Pasadena
country: United States
facility: Orion Medical
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Berlin-Mitte
country: Germany
facility: Juedisches Krankenhaus Berlin
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe
city: Fukuoka-ken
country: Japan
facility: Kokura Memorial Hospital
city: Kanagawa Prefecture
country: Japan
facility: Yokosuka Kyosai Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Oussama Wazni
role: PRINCIPAL_INVESTIGATOR
References: