CF² Study Rev.1 IMP
Research type
Research Study
Full title
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
IRAS ID
228193
Contact name
Doris Wächter
Contact email
Sponsor organisation
I-Med-Pro GmbH
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The CF² study is a prospective, randomized (1:1), multi-centre study of in total 350 participating patients. The study will take place in Germany, Belgium, the Czech Republic and the UK. The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of two groups of patients treated with either the HearLight endoscopically (with integrated camera) guided Laser balloon ablation catheter (CardioFocus) or with a Contact Force Sensing Irrigated Radiofrequency ablation catheter. The intervention (ablation) should eliminate the faulty electrical excitations in the heart of the patients suffering from paroxysmal (transitory) atrial fibrillation (AF). By applying circular ablation lines or lesions around the openings of the pulmonary veins in the left atrium the electrical triggers causing atrial fibrillation can be isolated . Electrial signals are no longer transmitted. After the procedure, patients will be followed up at 3, 6 and 12 months.The primary efficacy endpoint will be symptomatic, recurrent atrial fibrillation after a blanking period of 3 months, where recurrent AF is defined as any documented episode of AF lasting more than 30 seconds.The hypothesis of the study is that there will be no statistically significant difference in procedure, safety or clinical outcomes between the two groups. Secondary endpoints are : 1. Acute procedure success defined as the ability to confirm electrical isolation with a circular mapping catheter after a 30 minute waiting period. 2. Procedure and fluoroscopy time. 3. Incidence of peri-procedural complications ( e.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade. 4. Freedom of symptomatic, recurrent Atrial Tachy Arrhythmia. Both interventions are standard care in the UK.
REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0688
Date of REC Opinion
18 Dec 2018
REC opinion
Further Information Favourable Opinion