N/A
N=16
AF Septal Pacing (Clinical Investigation Plan)
Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03242941 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Electrodes in a Stable Position — 38 Electrode pairs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulmonary vein ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic BRC
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Electrodes in a Stable Position |
38 | — |
| SECONDARY Localized Atrial Capture |
8 | — |
| SECONDARY Termination of Atrial Tachyarrhythmia. |
3 | — |
Summary
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.
Eligibility Criteria
Inclusion Criteria
- Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
- In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
- Patient is willing and able to cooperate with the study procedure.
- Patient is willing to provide the Informed Consent for their participation in the study.
Exclusion Criteria
- Patients under 18 years or over 80 years old.
- Women who are currently pregnant or have a positive pregnancy test.
- Patients with an implantable cardiac device.
- Patients who already underwent an AF septal ablation procedure.
Data sourced from ClinicalTrials.gov (NCT03242941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.