Amplify EP Registry

NCT ID: NCT06669637

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ablation

Intervention Type DEVICE

Ablation procedure for Atrial Fibrillation

Interventions

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Ablation

Ablation procedure for Atrial Fibrillation

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Heart Rhythm Clinical and Research Solutions, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Kim Harbin

Role: CONTACT

256-591-0727

Courtney Muenchow

Role: CONTACT

Other Identifiers

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Amplify

Identifier Type: -

Identifier Source: org_study_id

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