Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF (RAPID-AF)

Biosense Webster

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: cartofinder guided ablation followed by PVI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03064451

RAPID-AF

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intervention

Experimental group

Description:

cartofinder guided ablation followed by PVI

Treatment:

Procedure: cartofinder guided ablation followed by PVI