Project 462675
Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area RadiofrEquency Ablation Compared to Cryoablation Pulmonary Vein Isolation- A Patient Specific Precise Approach To Paroxysmal Atrial Fibrillation Ablation: AWARE-2 RCT
Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area RadiofrEquency Ablation Compared to Cryoablation Pulmonary Vein Isolation- A Patient Specific Precise Approach To Paroxysmal Atrial Fibrillation Ablation: AWARE-2 RCT
Project Information
| Study Type: | Unclear |
| Research Theme: | Clinical |
Institution & Funding
| Principal Investigator(s): | Nair, Girish M; Andrade, Jason G; Birnie, David H; Essebag, Vidal; Wells, George A |
| Co-Investigator(s): | de Azeredo Coutinho, Thais; Joza, Jacqueline; Lewis, Krystina B; Macle, Laurent; Morillo, Carlos A; Nery, Pablo; Parkash, Ratika; Rivard, Léna; Roux, Jean-François; Sarrazin, Jean-François; Singh, Sheldon M; Skanes, Allan C; Sterns, Laurence D; Veenhuyzen, George D; Wong, Jorge A |
| Institution: | University of Ottawa Heart Institute |
| CIHR Institute: | Circulatory and Respiratory Health |
| Program: | |
| Peer Review Committee: | Randomized Controlled Trials |
| Competition Year: | 2022 |
| Term: | 5 yrs 0 mth |
Abstract Summary
STATEMENT OF THE HEALTH PROBLEM: Atrial Fibrillation (AF) is a heart rhythm disturbance that affects over a million people in Canada and the USA. If left untreated AF can cause strokes, heart failure, poor quality of life and may lead to premature death. In people with AF not benefitting from medications, a heart procedure using catheters has been shown superior be better for symptom control, prevention of stroke and heart failure. However, people undergoing this procedure may continue to have AF recurrences mainly because the catheter procedure was ineffective. OBJECTIVE OF TRIAL: The objective of our trial is to find out if a new method of performing the catheter procedure will be more effective in preventing AF recurrence. This new method studies factors causing AF in each individual to perform a precise, patient tailored catheter procedure. Subjects with AF (our patient partners) have found our research interesting and are eager to participate in the trial. The effectiveness and safety of the procedures will be specifically evaluated in women to understand the effect of sex on AF ablation. HOW WILL WE UNDERTAKE OUR TRIAL? We plan to enroll 580 subjects in the research study. Subjects will be allocated to the two treatment groups with the toss of a coin and will be followed up after the procedure to find out if they have AF recurrences. A decision aid, to help patients understand the trial will be used for improving the consent process from the patient's point of view. WHAT IS UNIQUE/INNOVATIVE ABOUT OUR PROJECT? Our trial is aimed at improving the success of the catheter procedure used to treat subjects with AF using a patient specific approach. If the new catheter procedure proves to be better than the currently used method, we expect substantial reduction in the incidence of recurrent AF. This should directly improve patient care with improved patient satisfaction, reduction in AF related disability, death and health care costs.
No special research characteristics identified
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