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

NCT ID: NCT03729830

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 415 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2024-05-03

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oussama Wazni

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Torrance Memorial Medical Center

Torrance, California, United States

Broward General Medical Center

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

St. Lukes Idaho Cardiology Associates

Boise, Idaho, United States

University of Chicago Hospital

Chicago, Illinois, United States

St. John's Hospital

Springfield, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Kaleida Health

Buffalo, New York, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

HeartPlace Mid-Cities EP

Bedford, Texas, United States

Orion Medical

Pasadena, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

Staedtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Juedisches Krankenhaus Berlin

Mitte, , Germany

Kokura Memorial Hospital

Fukuoka-ken, , Japan

Yokosuka Kyosai Hospital

Kanagawa Prefecture, , Japan

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Korea University Medical Center

Seoul, , South Korea

Papworth Hospital

Cambridge, , United Kingdom

Countries

United States; Germany; Japan; Monaco; South Korea; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

92249986

Identifier Type: -

Identifier Source: org_study_id