California's Central Valley is home to about five Kaiser-affiliated hospitals, offering emergency and other medical services 24 hours a day, seven cslifornia a week. West Lancaster, CA Driving directions References Kaiser Permanente: Quick Facts. Written by Max Stirner. Max Stirner is a New York-based writer and editor with over a decade of experience. Richmond, CA 1 0.
August 28, January 16, May 28, July 12, July 15, August 9, September 30, October 5, October 8, October 11, October 20, November 5, December 1, December 16, January 13, January 27, February 8, March 2, March 30, May 17, May 20, June 14, July 6, August 22, October 26, January 6, January 10, January 11, Study Status Record Verification:. FDA-regulated Drug:. Study Description Brief Summary:. This is a prospective, multi-center, randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm.
Conditions Conditions:. Study Design Study Type:. Randomized treatment versus control Control Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.
Control Right heart catheterization, invasive echocardiography. Experimental: Roll in Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation. Outcome Measures Primary Outcome Measures:. Safety-Percentage of Treatment patients experiencing major device-related adverse events [ Time Frame: days after randomization ] Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events MACNE during the first days after randomization, compared to a pre-specified Performance Goal.
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device LVAD implantation, HF hospitalizations, and change in Kansas City Cardiomyopathy Quesstionnaire KCCQ [ Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months ] Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method. Time to all-cause death or first heart failure hospitalization [ Time Frame: Baseline through study completion, maximum of five years ] Time to all-cause death or first heart failure hospitalization.
Cumulative heart failure hospitalizations [ Time Frame: Baseline through study completion, maximum of five years ] Cumulative heart failure hospitalizations. Time to first heart failure hospitalization [ Time Frame: Baseline through study completion, maximum of five years ] Time to first heart failure hospitalization. Eligibility Minimum Age:.
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