Health TrialsbyHealthPanel

Amplify EP Registry

ConditionAtrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHeart Rhythm Clinical and Research Solutions, LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ablation

    Device

    Ablation procedure for Atrial Fibrillation

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: Patients undergoing AF Ablation using TactiFlex catheter1 intervention

Trial outcomes

Primary outcomes

1

Long term effectiveness

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

Time frame
12-month

Secondary outcomes

1

Acute success

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

Time frame
at time of procedure
2

Acute safety

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

Time frame
30 days
3

Long term safety

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

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Rhythm Clinical and Research Solutions, LLC

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: