Amplify EP Registry

N/ANot Yet RecruitingNCT06669637

Heart Rhythm Clinical and Research Solutions, LLC1,100 enrolled

Overview

An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation

Study Type

OBSERVATIONAL

Enrollment

1,100

Conditions

Atrial Fibrillation

Interventions

AblationDEVICE

Ablation procedure for Atrial Fibrillation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation. * Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott. * De Novo or redo AF catheter ablation procedures. * Able and willing to participate in baseline and all follow up evaluations. * 18 years of age or older. Exclusion Criteria: * Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure. * In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.

Outcomes

Primary Outcomes

Long term effectiveness

defined as freedom from recurrence of AF/AT/AFL \>30 sec at 12-month follow-up

Time frame: 12-month

Secondary Outcomes

Acute success

ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only

Time frame: at time of procedure

Acute safety

rate of acute safety events defined as procedure or device related complications that occur within 7 days of the procedure and incidence per-procedural complications that occur greater than 7 days but less than 30 days post ablation

Time frame: 30 days

Long term safety

Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation.

Time frame: 12 months

Central Contacts

Kim Harbin

CONTACT

256-591-0727 kharbin@hrcrs.com

Courtney Muenchow

CONTACT

cmuenchow@hrcrs.com

Data from ClinicalTrials.gov

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