Amplify EP Registry

NCT06669637 | Not Yet Recruiting FDA Device

• 1 other identifier: Amplify
• Study Type: observational
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atrial Fibrillation

Keywords

Ablation; Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Long term effectiveness

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

  12-month

Secondary Outcomes (3)

• Acute success

  at time of procedure

• Acute safety

  30 days

• Long term safety

  12 months

Study Arms (1)

Patients undergoing AF Ablation using TactiFlex catheter

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

Device: Ablation

Interventions

Ablation DEVICE

Ablation procedure for Atrial Fibrillation

Patients undergoing AF Ablation using TactiFlex catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS

You may qualify if:

• 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.
• years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Rhythm Clinical and Research Solutions, LLC: lead
• Abbott: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kim Harbin

CONTACT

256-591-0727; kharbin@hrcrs.com

Courtney Muenchow

CONTACT

cmuenchow@hrcrs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share