Not yet recruiting NCT06669637
Amplify EP Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Device Ablation
Ablation procedure for Atrial Fibrillation
Primary outcome measures
- Long term effectiveness [Time frame: 12-month]
Secondary outcome measures (3)
- Acute success [Time frame: at time of procedure]
- Acute safety [Time frame: 30 days]
- Long term safety [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06669637 · Amplify