The CARMA Center at the University of Utah Health Care kicked off a clinical trial aiming to improve the treatment of atrial fibrillation (AF). Under the guidance of lead investigator Nassir Marrouche, M.D., the DECAAF II trial will evaluate the efficacy of targeting atrial fibrotic tissue during catheter ablation of AF in improving procedural outcome.
Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States. Each year millions of Americans are diagnosed and treated for this condition, which is an electrical problem in the upper chambers in the heart that causes an irregular heartbeat. Currently one of the most widely used treatments is catheter ablation that involves radiofrequency energy or freezing directed through a catheter to specific heart cells.
In the DECAAF II study two ablation protocols will be compared: the conventional Pulmonary Vein Isolation procedure versus ablation of atrial fibrotic tissue detected using MRI. "This study follows our initial work at the CARMA center including the initial DECAAF study," says Marrouche. "In that study we found that one of the most important predictors of a good outcome for AF patients was the amount of fibrotic tissue treated during ablation."
The DECAAF II study is working with the hypothesis that patients receiving fibrosis-guided ablation in addition to the conventional ablation will have fewer AF recurrences than those who receive conventional ablation alone.
Study participants will be randomized and treated with one of the two ablation techniques. After their treatment they will monitor their heart rhythm using the FDA-approved smartphone mobile ECG Check application. This will help determine if AF has recurred after treatment in addition to monitoring patients' quality of life.
Participants in the study will be enrolled at more than 30 clinical centers across the world including locations in North America, Asia, Europe, and Australia. More than 880 adults are expected to be enrolled in the DECAAF II study over the next two years.
"This study has the potential to change the way we manage millions of AF patients around the world", said Marrouche "We are not only presenting a new approach to treat AF, but also a novel way to monitor patients with AF using mobile smartphone technology". For more information please visit http://www.decaaf.org/.