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
Summary of Research
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.
Summary of Results
The INTERRUPT AF clinical study was required by the FDA. The study looked at both the short-term (up to one year) and long-term (up to three years) safety and effectiveness of the Rhythmia™ Mapping System used together with Boston Scientific Open-Irrigated (OI) Catheters to treat paroxysmal atrial fibrillation (PAF) — a type of irregular heartbeat that comes and goes.
The study met all of its main goals, showing that the system is both safe and effective.
Key Results:
Safety: 96% of patients had no serious complications within 30 days. No cases of pulmonary vein narrowing or damage to the esophagus were reported.
Effectiveness (main measure): About 55% of patients stayed free of atrial fibrillation or related problems one year after the procedure.
Effectiveness (secondary measure): About 71% of patients met additional success criteria at one year.
Procedure success: The ablation procedure itself worked as planned in 98% of cases.
DIRECTSENSE feature: In patients where this feature was used, the safety rate was again very high at 96%, showing similar strong results.
In summary:
The INTERRUPT AF study showed that using the Rhythmia Mapping System with Boston Scientific Open-Irrigated Catheters is a safe and effective treatment for people with paroxysmal atrial fibrillation.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