N/A
Completed N=16
AF Septal Pacing (Clinical Investigation Plan)
Source: ClinicalTrials.gov NCT03242941 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Number of Electrodes in a Stable Position — 38 Electrode pairs
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.
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 | — |
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. Informational only — not medical advice.