CONFORM
The CONFORM study evaluates the efficacy of a new left atrial appendage occlusion device in patients with nonvalvular atrial fibrillation.
About This Study
Summary
Approximately 10% of U.S. adults have atrial fibrillation—a rapid, irregular heartbeat—and most of that 10% have the type known as nonvalvular atrial fibrillation (NVAF). NVAF is particularly problematic because it can cause blood clots to form, leading to stroke. Treatment of NVAF usually includes anticoagulants (blood thinners) to prevent blood clots. But some people with NVAF can’t take anticoagulants for various reasons. Instead, these patients might receive a small, catheter-delivered appliance known as a Left Atrial Appendage Occlusion (LAAO) device, which eliminates the need for long-term blood thinners. LAAO devices close off the region of the heart where 90% of stroke-causing clots form in patients with NVAF.
The CONFORM study evaluates whether a new LAAO device works as well as other commercially available LAAO devices in patients with NVAF. Patients who are eligible for the study will be randomly assigned (50:50, like a coin toss) to receive either the study device or a commercially available device. Neither the participant nor the lead scientist can choose or will know which device the participant receives. Regardless of which device a participant receives, members of the research team will follow up with them for 5 years.
To be included in CONFORM, participants must be / have
- Adult (at least 18 years old)
- Confirmed diagnosis of NVAF
- Defined medical or other reason for seeking an alternative to anticoagulant therapy
- Considered to be appropriate for the study according to both the lead investigator and another clinician who is not a member of the research team
To be included in CONFORM, participants must not be / have
- Transient or reversible atrial fibrillation
- Active systemic infection
- Symptomatic coronary artery disease
- Severe heart failure
- Stroke, transient ischemic attack, or myocardial infarction within 30 days before planned study procedure
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
Keywords
Atrial fibrillation; Nonvalvular atrial fibrillation
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic, assistant professor of medicine at Virginia Tech Carilion School of Medicine, and director of Carilion's structural heart disease fellowship program. Dr. Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
Official title of study
The CONFORM Pivotal Trial, An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
Funding mechanism
Industry sponsored by Conformal Medical, Inc