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The CONFORM Pivotal Clinical Trial for People with AFib
Protocol: STUDY00006904
Full Title
The CONFORM Pivotal Trial: An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendag
Description
The University at Buffalo (UB) Department of Medicine is enrolling adults with atrial fibrillation (or “AFib”) that are worried about their risk of having a stroke. People with AFib have a heart condition that causes the upper chambers of their hearts to beat irregularly, or differently than they should. The goal of the study is to see if a new study device (the CLAAS System) can reduce the risk of stroke without the need for blood thinners.

Participants will be enrolled in this study for 5 years. Before the surgery, the study doctor will conduct a physical exam, lab tests, imaging tests, and surveys. Following the surgery to implant the study device, they will attend follow-up visits at 7 days, 45 days, 6 months, 12 month, 18 months, 2 years, 3 years, 4 years, and 5 years for physical exams, lab tests, imaging test, and surveys.
Compensation: No
Eligibility
Adults 18 years or older Have been diagnosed with atrial fibrillation (or AFib) Are at risk for stroke
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
RICHARD KARALUS
karalus@buffalo.edu
+1 716-888-4881
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115

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