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Ablation procedure and/or cardioversion

Phase 1

Atrial Fibrillation | Unknown | Cardiovascular |Medtronic plc.|Last Updated: Sep 19, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment53
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00744835Atrial Fibrillation Ablation Pilot StudyPHASE1 COMPLETED 53Aug 1, 2006Jul 1, 2008Sep 19, 20185 Netherlands, Switzerland +1
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Study Endpoints
Primary Endpoints
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
6 months
Secondary Endpoints
Effectiveness
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAblation Management
Interventions
NameTypeDescription
Ablation procedure and/or cardioversionPROCEDUREAblation Frontiers Cardiac Ablation System
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * History of symptomatic permanent atrial fibrillation * Age between 18 and 70 * Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study Exclusion Criteria: * Structural heart disease of clinical significance * ...

Countries:NetherlandsSwitzerlandUnited Kingdom
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