Cardialen CESS V5
Research type
Research Study
Full title
Measurement of Low-energy Stimulation in Patients with Atrial Fibrillation
IRAS ID
164828
Contact name
Nicholas Peters
Contact email
Sponsor organisation
Cardialen Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
The primary objective of the study is to evaluate the safety and performance of patients with atrial fibrillation when receiving treatment with the CESS device.
Atrial Fibrillation is a common problem which affects the rate of a person’s heartbeat. This can be that the heartbeat is too fast, too slow or with an irregular rhythm.
Cardialen External Stimulation System (CESS) is a device that uses a number of Therapies to restore atrial fibrillation back to a normal rhythm. Restoring the heart rhythm eases the patients’ symptoms and thereby is aimed at improving their quality of life.
CESS will deliver low-energy atrial stimulation therapy through a multi-stage process, this is delivered with Medtronic Sprint Quattro Defibrillation Leads which are placed into the heart.
This study involves the testing of the CESS device in patients with atrial fibrillation prior to their normal scheduled catheter insertion procedure (a procedure in which an electric current is used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). The low-voltage electric current enters the body through metal paddles or patches applied to the chest. This is the method typically used to treat atrial fibrillation.
45 subjects who show a current need for this type of treatment due to atrial fibrillation will receive the study therapy. This will include up to 5 sites worldwide, currently we have one site set up in France and one in the USA. Approvals are being sought for the study to be conducted at one site in Poland and another in the UK, each site will enrol and treat up to 15 patients.
The study therapy will be delivered with increasing voltages and timing sequence changes until atrial fibrillation is successfully finished. The study therapy may be completed multiple times within 60 minutes prior to the scheduled standard therapy.
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/2143
Date of REC Opinion
28 Jan 2015
REC opinion
Further Information Favourable Opinion