Clinical trial NCT03064451: Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
Official title: Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF Using the RHYTHMFINDER-192
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation - ablation procedure
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion).
timeFrame: Up to 7 days
measure: Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion
timeFrame: Up to 7 days
measure: Percentage of Participants With Procedural Success
timeFrame: Up to 7 days
measure: Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months
timeFrame: Up to 12 months
measure: Number of Participants With Early-onset Primary Adverse Events
timeFrame: Up to 7 days
Secondary outcomes:
measure: Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge
timeFrame: Up to 12 months
measure: Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI
timeFrame: Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days)
measure: Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months
timeFrame: Up to 12 months
measure: Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months
timeFrame: Up to 12 months
measure: Number of Participants With Adverse Device Effects (ADEs) up to 12 Months
timeFrame: Up to 12 months
measure: Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice
city: London
country: United Kingdom
facility: St Bartholomew's hospital
city: London
country: United Kingdom
facility: London Health Sciences Center
Study officials:
References: