Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study
PREPARE-TAVR
PREPARE-TAVR
Sponsor study identifier
interventional
160
1 country
1
Study Start
July 1, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2019
Actual (reported)January 11, 2019
Actual (reported)July 1, 2020
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Quality of Life (QOL)
Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best.
One year
LOS
Index hospitalization
MACE
one year
Standard of Care
Remotely administered physiological reconditioning program
Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Southlake Hospital
Newmarket, Ontario, Canada
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Asim Cheema, MD
Unity Health Toronto
First Submitted
January 9, 2019
First Posted
January 11, 2019
Study Start
July 1, 2020
Actual (reported)Primary Completion
Promoting Movement in Older Adults in the Community
Contact the study team to confirm eligibility.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 13, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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