Telemedicine monitoring of patients with severe aortic stenosis and planned transcatheter aortic valve implantation (TAVI) under normal conditions and when treatment capacity is limited due to crisis.

Telemedicine monitoring of patients with severe aortic stenosis and planned transcatheter aortic valve implantation (TAVI) under normal conditions and when treatment capacity is limited due to crisis. - ResKriVer-TAVI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027842

Enrollment

200

Registered

2022-05-16

Start date

2022-06-09

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

I35.0

Interventions

Group 1: Telemedical monitoring pre-TAVI Group 2: Standard care

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patient with decision for TAVI in case of severe aortic stenosis in the heart team, age of majority, written consent of the patient.

Exclusion criteria

Exclusion criteria: Inability or unwillingness to take daily vital signs (e.g., dementia, blindness, deafness, wheelchair use, insufficient German language skills, limited informal self-determination), Participation in therapy studies (observational studies and registries are possible).

Design outcomes

Primary

Measure	Time frame
Days lost due to unplanned cardiovascular hospitalisations and all-cause mortality up to 180 days after heart team decision	—

Secondary

Measure	Time frame
Days lost due to unplanned cardiovascular hospitalisations up to 180 days after heart team decision, Days lost due to all-cause mortality up to 180 days after heart team decision, Death of any cause up to 180 days after heart team decision, Death of any cause up to 365 days after cardiac teament separation, Rate of unplanned cardiovascular hospitalizations up to 180 days after heart team decision, Number of hospitalizations due to cardiac decompensation (rate, duration) up to 180 days after heart team decision, Number of telemedicine interventions during preoperative telemedicine monitoring, Number of telemedicine-induced admissions during preoperative telemedicine monitoring, Adherence to telemonitoring during preoperative telemedicine monitoring, Postponement of TAVI appointment due to medical reasons (reported in days), Quality of life according to the PROMIS-29+2 questionnaire (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision), NYHA class (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision), GFR (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision)	—

Measure

Time frame

Days lost due to unplanned cardiovascular hospitalisations up to 180 days after heart team decision, Days lost due to all-cause mortality up to 180 days after heart team decision, Death of any cause up to 180 days after heart team decision, Death of any cause up to 365 days after cardiac teament separation, Rate of unplanned cardiovascular hospitalizations up to 180 days after heart team decision, Number of hospitalizations due to cardiac decompensation (rate, duration) up to 180 days after heart team decision, Number of telemedicine interventions during preoperative telemedicine monitoring, Number of telemedicine-induced admissions during preoperative telemedicine monitoring, Adherence to telemonitoring during preoperative telemedicine monitoring, Postponement of TAVI appointment due to medical reasons (reported in days), Quality of life according to the PROMIS-29+2 questionnaire (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision), NYHA class (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision), GFR (at the time points baseline visit, Z1=admission for TAVI, Z2=180 days after heart team decision)

—

Countries

Germany

Contacts

Public ContactIsabel Mattig

Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Campus Charité Mitte, Berlin, Germany.

isabel.mattig@charite.de+49 30 450 513 142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026