Amplify EP Registry

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ablation

Device

Ablation procedure for Atrial Fibrillation

Primary outcomes

Long term effectiveness

Time frame: 12-month

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

Secondary outcomes

Acute success

Time frame: at time of procedure

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

Time frame: 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

Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Muenchow

CONTACT

[email protected]

Kim Harbin

CONTACT

[email protected]

256-591-0727

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

Abbott

Registry information

Acronym: AMP

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Nov 1, 2024
Registry last updated: Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting