Status:
COMPLETED
AF Septal Pacing (Clinical Investigation Plan)
Lead Sponsor:
Medtronic BRC
Conditions:
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 s...
Detailed Description
The evidence of treating AF by pacing is limited, although these algorithms are of interest, since they appear to be safe and usually add little additional cost. Using a computer model, a new dual-st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03242941
Start Date
April 26 2018
End Date
December 21 2018
Last Update
November 4 2019
Active Locations (3)
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1
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary, 1096
2
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, Netherlands, 6229 HX
3
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM