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.
Investigators
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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