Recent Updates
Recently added Catalysts

Ablation procedure and/or cardioversion

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Ablation procedure and/or cardioversion · 1 trial · 1 indication

Phase 1 1
NCT00744835Atrial Fibrillation Ablation Pilot StudyAtrial Fibrillation
COMPLETED53 Analytics
PHASE1COMPLETED
Atrial Fibrillation Ablation Pilot Study
Atrial FibrillationUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Ablation procedure and/or cardioversion

What is the ablation procedure and/or cardioversion by Medtronic used for?

The ablation procedure and/or cardioversion is used for atrial fibrillation, a heart rhythm disorder. It is a cardiovascular treatment developed by Medtronic plc. The procedure is intended to address abnormal heart rhythms in patients with this condition.

Who makes the ablation procedure and/or cardioversion?

Medtronic plc (NYSE: MDT) develops the ablation procedure and/or cardioversion. This cardiovascular treatment is part of Medtronic's portfolio for managing atrial fibrillation. The company is a major medical device manufacturer.

What phase is the ablation procedure and/or cardioversion in?

The ablation procedure and/or cardioversion is in Phase 1 clinical development. It is an investigational treatment for atrial fibrillation. The Phase 1 trial has been completed, and the treatment is not yet approved for commercial use.

What clinical trials is the ablation procedure and/or cardioversion in?

The ablation procedure and/or cardioversion has one completed clinical trial, NCT00744835, titled "Atrial Fibrillation Ablation Pilot Study." This Phase 1 study enrolled 53 participants with atrial fibrillation and was conducted in the Netherlands, Switzerland, and the United Kingdom.

Is the ablation procedure and/or cardioversion FDA approved?

The ablation procedure and/or cardioversion is not FDA approved. It is an investigational treatment currently in Phase 1 clinical development. The completed pilot study provides preliminary data, but the treatment has not yet received regulatory approval.