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Prospective study on safety of remote cardiac rehabilitation for patients after TAVI

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032200122
Enrollment
15
Registered
2020-10-01
Start date
2021-05-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing TAVI due to severe aortic valve stenosis

Interventions

Remote cardiac rehabilitation using remote monitoring system

Sponsors

Ashikaga Kohei
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 11. Patients who do not have an internet communication system at home 12. Patients who have already participated in or plan to participate in other clinical trials during this trial 13. Patients who are not able to understand the significanse of clinical investigation because of the dementia or other psychiatric disease 14. Any other person who is deemed inappropriate by the Research Director

Design outcomes

Primary

MeasureTime frame
Safety of remote cardiac rehabilitation

Secondary

MeasureTime frame
Peak oxygen uptake, Anaerobic threshold, 6-minutes walk distanse, Knee extension strength, NT-proBNP, Steps (per day), Short Physical Performance Battery, controlling nutritional status, Remote cardiac rehabilitation implementation rate, Cardiovascular prognosis, Total death

Contacts

Public ContactKohei Ashikaga

St. Marianna University School of Medicine

k2ashikaga@marianna-u.ac.jp+81-44-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026