Amplify EP Registry (AMP)

Heart Rhythm Clinical and Research Solutions (HRCRS)

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Ablation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06669637

Amplify

Details and patient eligibility

About

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

Enrollment: 1,100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,100 participants in 1 patient group

Patients undergoing AF Ablation using TactiFlex catheter

Description:

patients undergoing de novo or redo AF ablation procedures using TactiFlex ablation catheter following patients up to 6 to 12 months follow up.

Treatment:

Device: Ablation