HEAL-IST: Sinus node sparing ablation therapy for IS Tachycardia
Research type
Research Study
Full title
Hybrid Epicardial and Endocardial Sinus Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia.
IRAS ID
325039
Contact name
Jonathan Sahu
Contact email
Sponsor organisation
AtriCure, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 1 days
Research summary
This is a prospective single arm study targeting patients with a cardiac condition called Inappropriate Sinus Tachycardia (IST), which is a rapid heartbeat. This condition is most common in young adults. It significantly affects their quality of life and there is no proven effective therapy for their condition. This study is testing the hybrid sinus node saving ablation procedure. An ablation procedure is a procedure in which a heart specialist creates isolating lines in on the heart. These lines cause scars that stop electrical stimuli from passing through in certain places of the heart that may be responsible for the disease. The ISOLATOR® Synergy Surgical Ablation System by AtriCure is used in this study. The study looks at how safe the ISOLATOR® Synergy Surgical Ablation System medical device is and how well it works in patients with IST. Up to 142 subjects will be enrolled at up to 40 sites in the US, UK and EU. Each subject will be followed for 2 years.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0220
Date of REC Opinion
25 Sep 2023
REC opinion
Further Information Favourable Opinion