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Clinical Trials/JPRN-jRCTs032200122
JPRN-jRCTs032200122
Completed
Phase 3

Prospective study on safety of remote cardiac rehabilitation for patients after transcatheter aortic valve implantation

Ashikaga Kohei0 sites12 target enrollmentOctober 1, 2020

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Patients undergoing TAVI due to severe aortic valve stenosis
Sponsor
Ashikaga Kohei
Enrollment
12
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Cardiac rehabilitation using a remote monitoring system was safe and effective, suggesting its feasibility.

Registry
who.int
Start Date
October 1, 2020
End Date
March 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ashikaga Kohei

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients who will perform outpatient cardiac rehabilitation
  • 2\. Patients who were hospitalized at St. Marianna University Hospital, received transcatheter aortic valve transplantation, and started cardiac rehabilitation during hospitalization
  • 3\. Patients who gained document consent by free will of the research subject after having sufficient explanation for participation in this research, with sufficient understanding.
  • 4\. Men and women over 20 years old
  • 5\. Patients who can be accompanied by an attendant every time remote cardiac rehabilitation is performed

Exclusion Criteria

  • 1\. Patients who are NYHA class 3 or 4
  • 2\. Patients who had cerebral infarction after TAVI
  • 3\. Patients who had myocardial infarction within one month
  • 4\. Patients who have unknown or untreated syncope or cardiac arrest
  • 5\. Patients who had history of proper and inappropriate operation of ICD/CRT\-D, syncope, and cardiopulmonary arrest within the last 6 months
  • 6\. Patients who have uncontrolled angina pectoris
  • 7\. Patients with adverse events due to exercise at the anaerobic threshold during the first symptom limited exercise test and out\-patients cardiac rehabilitation
  • 8\. Patients who have severe renal dysfunction
  • 9\. Patients who have severe liver dysfunction
  • 10\. Patients who are difficult to operate the system of remote cardiac rehabilitation

Outcomes

Primary Outcomes

Not specified

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