Status:
COMPLETED
AutoMatic disPERsion Tagging Function Preliminary Evaluation
Lead Sponsor:
Volta Medical
Conditions:
Atrial Fibrillation
Atrial Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bid...
Detailed Description
Ablation of Atrial Fibrillation (AF) and Atrial Tachycardia (AT) is typically performed in predetermined anatomic regions of the left atrium (pulmonary veins isolation) and may be supplemented by a ta...
Eligibility Criteria
Inclusion
- Patient aged 18 years or older.
- Patient candidate for catheter ablation of atrial tachycardia, or paroxysmal or persistent atrial fibrillation, de novo or after one or several previous ablation procedures.
- Continuous anticoagulation for more than 4 weeks before ablation.
- Patient giving his signed consent form to participate in the clinical study.
- Patient affiliated to the French social security
Exclusion
- Contraindication to AF/AT catheter ablation.
- Major bleeding disorder.
- Contraindication to anticoagulation (Heparin, Warfarin or novel oral anticoagulants (NOAC)) or lack of anticoagulation for 4 weeks prior to the procedure.
- Presence of a left atrium (LA) thrombus on transesophageal echocardiography (TEE) prior to the procedure.
- Patient who is or could potentially be pregnant.
- Person deprived of liberty or under guardianship.
- Patient's refusal to participate in the study.
Key Trial Info
Start Date :
May 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05362656
Start Date
May 29 2022
End Date
December 9 2022
Last Update
November 22 2023
Active Locations (1)
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1
Hôpital Saint-Joseph
Marseille, France, 13008