Amplify EP Registry

Not yet recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06669637
• Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Study Start: 2024-11-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term effectiveness	12-month	defined as freedom from recurrence of AF/AT/AFL \>30 sec at 12-month follow-up

Secondary Outcome Measures

Name	Time	Method
Acute success	at time of procedure	ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only
Acute safety	30 days	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
Long term safety	12 months	Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation.