WATCHMAN Asia Pacific Registry (WASP)
Royal Adelaide Hospital, Boston Scientific Corporation, Greenslopes, Monash Medical, Sydney Adventist, Prince of Wales Hospital, Queen Elizabeth Hospital, Medistra Hospital, Severance Hospital, Institut Jantung Negara, Ramathibodi Hospital
This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE-CRT MPP)
Royal Adelaide Hospital, St. Jude Medical, Amsterdam Academic Medical Center (AMC)
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)
University of Adelaide, Medtronic, St. Jude Medical, Boston Scientific Corporation
Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an established treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An important subset of heart failure patients are those with atrial fibrillation (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in sinus rhythm, due to competition between beats generated by the CRT device and beats conducted from the heart's own electrical conduction system. In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.
HELP-AF: A randomised controlled trial assessing Home-based Education and Learning Program for Atrial Fibrillation
University of Adelaide, Royal Adelaide Hospital, Flinders Medical Centre, Daw Park Repatriation Hospital, Modbury Hospital, Queen Elizabeth Hospital, Lyell McEwin Hospital
Atrial fibrillation (AF) is the most common abnormal heart rhythm in the population and its prevalence is rapidly increasing. Sufferers of atrial fibrillation have a significantly impaired quality of life and their medical management is placing a growing burden on the Australian health care system. The proposed study will examine whether a home-based education program, will reduce hospital use and improve quality of life in AF patients compared to those patients who experience usual medical care.
Implications of aggressive cardiac risk factor management on the catheter ablation for atrial fibrillation (ARREST-AF)
University of Adelaide, Royal Adelaide Hospital, Royal Melbourne Hospital
Catheter ablation of atrial fibrillation (AF) has evolved as an effective therapy for drug-refractory AF, and the indications have broadened in recent years. Despite decreased procedural times, reduced complication rates, post-ablation freedom from AF has not improved proportionately in recent years. Metabolic syndrome (MS) and its components, including obesity, hypertension, diabetes, and dyslipidemia in conjunction with obstructive sleep apnoea, excessive alcohol intake and smoking, has been associated with increased incidence of AF. However, the impact of modifications of these risk factors on recurrence of AF after catheter ablation is unclear and has not been tested prospectively. Also, these patients are typically not included in risk-factor reduction programs. The purpose of the study is to evaluate the impact of a structured weight management program as part of the management of atrial fibrillation. It is also intended to assess the effect of weight reduction on the efficacy of atrial fibrillation following catheter ablation and the effect of weight and risk factor management on autonomic tone/pro-arrhythmic substrate.
Impact of pacemaker on cardiac function
University of Adelaide, Medtronic
Right ventricular apical (RVA) pacing results in abnormal left ventricular (LV) electrical and mechanical activation and is associated with adverse effects on left ventricular systolic function. The comparative effects of right ventricular outflow tract septal (RVOTS) pacing on cardiac structural remodeling are unknown. Our aim is to therefore examine the long-term effects of septal RVOT versus RVA pacing on ventricular and atrial structure and function using cardiac magnetic resonance imaging (CMR). The results of the study will provide new information about the potential benefits in mechanical function and consequent clinical endpoint(s) of septal versus apical pacing.
Feasibility Study to assess the performance of IntellaTip MiFiTM XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter
Royal Adelaide Hospital, Boston Scientific Corporation
The ablation procedure uses tools called catheters to treat the atrial flutter. Ablation catheters are thin, flexible plastic tubes that use electrical energy to stop abnormal heart rhythms by heating (ablating) and destroying a small area of tissue to break the abnormal pathway. The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter that is used to treat atrial flutter. The new catheter is called the Intellitip MiFi XP Ablation Catheter.
A new way of selecting atrial electrograms for ablation
Royal Adelaide Hospital
Atrial fibrillation (AF) is a disorganised abnormal heart rhythm which causes the heart to beat in an irregular fashion. Current curative ablation methods are based on targeted circles of burns around the openings of the pulmonary veins which are connected to the left atrium (or "top chamber") of the heart. We call this part of the procedure pulmonary vein isolation. In some patients, pulmonary vein isolation alone is not enough to cure their AF. In this case, the conventional strategy is to apply additional burns in special sites in the atrium with irregular local electrical signals. These areas are called complex fractionated atrial electrogram sites (or CFAE, pronounced like ‘café'). We believe, however, that other areas that may be selected with novel computational algorithms may be important to sustaining AF in many patients. The aim of this project is to examine whether burns targeting these sites in the atrium will improve control of AF, and improve cure rates for ablation.
Accuracy and clinical outcomes of CARTOSOUND compared to electro-anatomical mapping for atrial fibrillation ablation: A randomised controlled study
University of Adelaide, Royal Adelaide Hospital
In the last decade, catheter ablation procedures for atrial fibrillation (AF) have increased dramatically and this therapy is now a well entrenched treatment option for drug-refractory AF. The technology associated with mapping the atrial anatomy and localization of catheters within the heart has concurrently evolved to meet the demands of pulmonary vein isolation procedures for paroxysmal AF and a variety of adjunctive substrate ablation approaches for non-paroxysmal AF.
Navigation technologies aim to improve clinical outcome, increase safety, reduce procedure times and reduce X-ray exposure for AF ablation procedures. Compared to fluoroscopy led ablation, early randomized trials reported shorter procedure times and reduced X-ray for adjunctive virtual 3D mapping. Non-randomized trials/registries have suggested that adding CT/MRI merge capabilities to 3D mapping provides incremental benefit over 3D mapping alone; however, randomized trials have proven that the addition of CT/MRI merge capabilities to 3D mapping systems may be associated with negligible impact on clinical results and/or X-ray use. Furthermore, randomized evidence for new radiographic mapping technologies (3D rotational angiography) and early data on robotic sheath navigation also result in equivalence compared to standard 3D guided procedures.
Prior studies have demonstrated the efficacy of intracardiac echocardiography (ICE) for guiding ablation at the pulmonary vein ostia, within the cavotricuspid isthmus and for detection of left atrial thrombus and assessment of left atrial appendage mechanical function. In addition, one recent case series has reported ‘flouro-less' AF ablation procedures with ICE as an adjunct to 3D mapping.
CARTOSOUND integrates ICE into a 3D mapping system, such that the CARTO system can visualize the location and orientation of a specialized ICE catheter to enable the construction of a 3D geometry from a series of 2D ultrasound slices. CARTOSOUND has been validated in an animal model, tested in several clinical patient series and its unique utility is described in case reports. However, there have been no studies that have assessed the impact of CARTOSOUND mapping/navigation on AF ablation outcomes as compared to conventional EAM.
We sought to compare clinical parameters and mapping accuracy between CARTOSOUND and EAM mapping/navigation for AF ablation procedures via a randomized controlled trial.
Efficacy of coronary sinus ablation for treatment of atrial fibrillation
Royal Adelaide Hospital
The coronary sinus shares similar morphological and electro-anatomical characteristics to pulmonary veins, which have already been established as arrhythmogenic triggers of AF, but the former structure has received relatively sparse attention. The coronary sinus has been indirectly implicated in atrial arrhythmias; however, no one has systematically assessed the clinical efficacy of ablating this structure in addition to the conventional AF ablation approach.
The study aims to establish irrevocably, in a blinded randomised controlled comparison, whether or not the coronary sinus plays a role in maintaining AF in non-lone/long episode paroxysmal and persistent AF.
Weight management and Atrial Fibrillation: The impact of weight and risk factor management on AF burden in overweight and obese patients
University of Adelaide, Royal Adelaide Hospital
The purpose of the study is to evaluate the impact of a structured weight managment program as part of the management of atrial fibrillation. It is also intended to assess the effect of weight reduction on the efficacy of atrial fibrillation following catheter ablation and the effect of weight and risk factor management on autonomic tone/pro-arrhythmic substrate.
Atrial Fibrillation Progression Trial (ATTEST)
Royal Adelaide Hospital, Biosense Webster Inc., currently 38 study locations
The purpose of this study is to determine whether early radiofrequency ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with Paroxysmal AF (PAF), delays progression of atrial fibrillation compared with drug therapy (either rate or rhythm control) using current atrial fibrillation management guidelines.
A randomized, double blind, placebo-controlled, parallel, international multicenter study assessing the efficacy of S066913 in patients with paroxysmal atrial fibrillation (DIAGRAF - IKUR)
Australia, Canada, Czech Republic, Denmark, Germany, Netherlands, Poland, Russian Federation, Slovakia, Sweden, Institut de Recherches Internationales Servier
Main objective of the trial: Evaluation of the efficacy of 3 doses of S066913 (5mg, 25mg, 100mg) versus placebo administered for 4 weeks on atrial fibrillation and/or atrial tachycardia burden in patients with paroxysmal atrial fibrillation who have an indication for atrial fibrillation ablation and are implanted with insertable cardiac monitoring device.