The FDA, in conjunction with other organizations, has initiated the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI), which will help define clinical practice of long-term persistent atrial fibrillation (AF) ablation, according to a paper published in this month's American Heart Journal.
SAFARI, spearheaded by the Cardiac Safety Research Consortium, is intended to develop a more specific framework for the field of AF ablation, disseminate ablation guidelines to the medical community and collect outcomes and key performance indicators.
In addition, SAFARI will aim to:
- Support synergistic and collaborative efforts to bridge the knowledge gaps that exists in the field of AF ablation;
- Inform regulatory decision making as appropriate; and
- Inform related activities including clinical trials and professional society guidelines on the application of ablative therapies for AF.
The rollout of SAFARI will consist of six phases, beginning first with a pilot program, that will then be followed by the implementation phase, which includes training, enrollment and the monitoring of quality data.
Those involved offered that aspects of the registry, including determining governance and management—data management and analysis plans—regulatory and legal issues and funding, could arise as potential challenges during implementation.
“Funds are needed for managing committees, accounts and contracts, recruiting patients, marketing, providing clinical support, orientation and training, and developing data collection tools,” Sana M. Al-Khatib, MD, of the Duke Clinical Research Institute, Duke University Medical Center in Durham, N.C., and colleagues wrote.
The authors said that deciphering how much funding is necessary for SAFARI will be based on the magnitude and quality of the data being collected and recorded and the length and magnitude of the data collection itself.
The potential funding sources for SAFARI include annual participant fees, government funding or awards or industry funding.
The authors have looked into combining SAFARI participation to reimbursement, but some do not support this approach because sufficient data have yet to exist on the specific guidelines for AF ablation procedures.
Additionally, the authors said that the safety of AF ablation should further be studied, particularly where the procedure should be performed—academic, nonacademic or low- or high-volume centers—and operator experience.
The authors noted that the procedure’s outcomes in elderly patients, those with heart failure or other chronic conditions, should be further examined.
“SAFARI is increasingly recognized as an initiative that has the potential to provide important information on AF ablation in routine clinical practice especially in relation to this procedure's safety, effectiveness, and durability,” the authors concluded. “It can help improve quality and can offer a platform for benchmarking, quality measure development and postmarket product surveillance.”
SAFARI was originally proposed at a 2009 Cardiac Safety Research Consortium Think Tank meeting.