Ablation in Brugada Syndrome for the Prevention of VF



Status:Not yet recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:July 2016
End Date:July 2021
Contact:Koonlawee Nademanee, MD
Email:koonlawee@pacificrimep.com
Phone:3106729999

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Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence

This trial aims to develop evidence based curative treatment with optimal net benefit for
patients with Brugada syndrome.

This trial aims to develop evidence based curative treatment with optimal net benefit for
patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case
reports documented potential clinical benefit of epicardial ablation of fragmented
electrograms in the region of the right ventricular outflow tract, patients in this trial
will be randomized to continued implanted cardioverter defibrillator therapy (control arm)
or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus
continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92
patients in each group will be studied.

Inclusion Criteria:

- The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document
criteria

- The patient received at least 1 appropriate ICD shock

- The patient is legally competent, willing and able to undergo the study and signed
the informed consent

- The patient is willing and able to adhere to the follow-up visit protocol

Exclusion Criteria:

- A patient who does not meet inclusion criteria

- A patient who has had a previous epicardial ablation

- A patient who is pregnant (which would exclude an ablation procedure)

- A patient with a co-morbid condition that possesses undue risk of general anesthesia
or epicardial ablation

- A patient who has a history of radiation therapy on the thorax
We found this trial at
2
sites
Los Angeles, California 90033
Principal Investigator: Koonlawee Nademanee, MD
Phone: 310-672-9999
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Los Angeles, CA
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Amsterdam,
Principal Investigator: Pieter G Postema, MD PhD
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Amsterdam,
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