INTERRUPT AF
Research type
Research Study
Full title
Prospective EvaluatIoN Of Open IrrigaTEd Ablation CatheteRs With High ResolUtion MapPing To Treat Paroxysmal Atrial Fibrillation
IRAS ID
254266
Contact name
Claire Martin
Contact email
Sponsor organisation
Guidant Europe SA/NV, a Boston Scientific Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 5 months, 31 days
Research summary
The INTERRUPT AF study is designed to collect data to better understand the short and long term outcomes of the treatment of Paroxysmal Atrial Fibrillation (PAF)using the Rhythmia Mapping System and Boston Scientific Open-Irrigated Ablation catheters.
This information can also help to understand which future research studies may be needed.The ablation procedure that the doctor will perform is not part of this study, it will be the same procedure that a patient would complete if they were not participating in the study.
All participants fitting the enrolment criteria, who sign the consent and undergo the index ablation procedure with the study devices will be followed up for three years to complete the Post approval clinical study design mandated from the FDA to collect post-market data for Boston Scientific Open-Irrigated Catheters.
REC name
South East Scotland REC 01
REC reference
19/SS/0051
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion