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RF catheter ablation

Phase 1

Atrial Fibrillation | Unknown | Cardiovascular |Becton, Dickinson and Company|Last Updated: Jun 19, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

RF catheter ablation · 1 trial · 1 indication

Phase 1 1
NCT00265629RF Ablation of Atrial FibrillationAtrial Fibrillation
COMPLETED20 Analytics
PHASE1COMPLETED
RF Ablation of Atrial Fibrillation
Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety of the HDMA when used to map & ablate patients with AF, by assessing MCs at 7-days & 30 days post-procedure & assessing the occurrence of pulmonary vein stenosis at 3 & 12 months post-procedure.
12 months
Evaluate the preliminary effectiveness of the HDMA when used to map and ablate patients with paroxysmal AF, by assessing APS & the freedom from recurrence of symptomatic AF at 3, 6 & 12 months post- procedure.
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRF ablation

Interventions

NameTypeDescription
RF catheter ablationDEVICERF ablation using mesh device
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients who are between 18 \& 85 years of age. 2. Patients with a minimum of 2 episodes of symptomatic PAF within the last 6 months prior to baseline evaluation. At least one of these episodes must have been documented. Documentation may include electrocardiogram (ECG), tran...

Countries:United States
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Frequently asked questions about RF catheter ablation

What is RF catheter ablation used for in atrial fibrillation?

RF catheter ablation is used to treat atrial fibrillation, a heart rhythm disorder. The procedure uses radiofrequency energy to create small scars in heart tissue, which can help block abnormal electrical signals that cause irregular heartbeats. It is an investigational treatment in clinical development for this condition.

Who makes RF catheter ablation?

RF catheter ablation is developed by Becton, Dickinson and Company, a medical technology company traded on the New York Stock Exchange under the ticker BDX. The company is conducting clinical research to evaluate the procedure for treating atrial fibrillation.

What phase is RF catheter ablation in?

RF catheter ablation is in Phase 1 clinical development for atrial fibrillation. It is an investigational procedure and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and feasibility in patients.

What clinical trials is RF catheter ablation in?

RF catheter ablation has one completed clinical trial, NCT00265629, titled 'RF Ablation of Atrial Fibrillation'. This Phase 1 study enrolled 20 participants in the United States and evaluated the procedure in patients with atrial fibrillation. The trial was not randomized or blinded.

Is RF catheter ablation the same as catheter ablation?

RF catheter ablation is a specific type of catheter ablation that uses radiofrequency energy to treat atrial fibrillation. While the term 'catheter ablation' can refer to various energy sources, RF catheter ablation specifically denotes the use of radiofrequency energy for this procedure.