Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF

NCT ID: NCT03064451

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-04-10

Brief Summary

The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is investigational, while the CARTOFINDER™ system is CE marked in Europe.

All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening. The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12 months postprocedure.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

cartofinder guided ablation followed by PVI

Group Type: EXPERIMENTAL

cartofinder guided ablation followed by PVI

Intervention Type: PROCEDURE

cartofinder guided ablation followed by PVI

Interventions

cartofinder guided ablation followed by PVI

cartofinder guided ablation followed by PVI

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age > 18 years.

2. Patients who have signed the Patient Informed Consent Form (ICF)

3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of

1. persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).

2. drug-resistant atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate AF)

4. In AF at the time of the baseline CARTOFINDER™ Map (spontaneous)

5. Left Atrium (LA) must demonstrate sufficient electrical activity to allow for the identification of ablation targets.

6. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)

Exclusion Criteria

1. Paroxysmal Atrial Fibrillation

2. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) Subjects previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the ability to maintain Normal Sinus Rhythm for >30 days after cardioversion and have not been in AF greater than 1 year at the time of the procedure remain eligible for inclusion.

3. Previous ablation procedure for PsAF (defined as ablations involving more than only PV isolation)

4. Patients with a left atrial size >55 mm (echocardiography, parasternal long axis view).

5. Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.

6. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

7. Atrial arrhythmia patients with structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.

8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor).

9. significant pulmonary disease, cardiac surgeries, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.

10. Current enrollment in a study evaluating another device or drug.

11. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

12. Any cardiac surgery within the past 60 days (2 months) (includes PCI)

13. Subjects that have ever undergone valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)

14. Prior ICD or pacemaker implanted

15. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

16. Presence of a condition that precludes vascular access.

17. Subject has a contra-indication to the device under study per the IFU

18. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OLV Aalst

Aalst, , Belgium

AZ Sint-Jan Brugge

Bruges, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Nemocnice České Budějovice

České Budějovice, , Czechia

St Bartholomew's hospital

London, , United Kingdom

London Health Sciences Center

London, , United Kingdom

Countries

Belgium; Canada; Czechia; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RAPID-AF

Identifier Type: -

Identifier Source: org_study_id