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

NCT03064451 | Completed Results DMC FDA Device

• 1 other identifier: RAPID-AF
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 7

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

Keywords

persistent atrial fibrillation - ablation procedure

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion).

  Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation \[PVI\] and without cardioversion).

  Up to 7 days

• Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion

  Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion.

  Up to 7 days

• Percentage of Participants With Procedural Success

  Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion.

  Up to 7 days

• 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

  Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes \>= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring.

  Up to 12 months

• Number of Participants With Early-onset Primary Adverse Events

  Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding.

  Up to 7 days

Secondary Outcomes (6)

• Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge

  Up to 12 months

• Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI

  Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days)

• Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months

  Up to 12 months

• Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months

  Up to 12 months

• Number of Participants With Adverse Device Effects (ADEs) up to 12 Months

  Up to 12 months

Study Arms (1)

Intervention

EXPERIMENTAL

cartofinder guided ablation followed by PVI

Procedure: cartofinder guided ablation followed by PVI

Interventions

cartofinder guided ablation followed by PVI PROCEDURE

cartofinder guided ablation followed by PVI

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Patients who have signed the Patient Informed Consent Form (ICF)
• Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of
• persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).
• 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)
• In AF at the time of the baseline CARTOFINDER™ Map (spontaneous)
• Left Atrium (LA) must demonstrate sufficient electrical activity to allow for the identification of ablation targets.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)

You may not qualify if:

• Paroxysmal Atrial Fibrillation
• Previous ablation procedure for PsAF (defined as ablations involving more than only PV isolation)
• Patients with a left atrial size \>55 mm (echocardiography, parasternal long axis view).
• Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• 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.
• History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor).
• 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.
• Current enrollment in a study evaluating another device or drug.
• A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Any cardiac surgery within the past 60 days (2 months) (includes PCI)
• Subjects that have ever undergone valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Prior ICD or pacemaker implanted
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
• Presence of a condition that precludes vascular access.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (7)

OLV Aalst

Aalst, 9300, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2060, Belgium

Location

Southlake Regional Health Centre

Newmarket, Ontario, ON L3Y 2P9, Canada

Location

Nemocnice České Budějovice

České Budějovice, 370 01, Czechia

Location

St Bartholomew's hospital

London, EC1A 7BE, United Kingdom

Location

London Health Sciences Center

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nathalie Macours / Clinical Research Director
• Organization: Johnson and Johnson Medical NV/SA

nmacours1@its.jnj.com

+32 2 746 35 27

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: February 22, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: May 11, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-05

Locations

BE (3); CA (1); GB (2); CZ (1)