CompletedNo phase
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
Key facts
- Who runs it
- German Heart Institute
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 1,000 people enrolled
- Started
- 7 Feb 2022
- Ended
- 28 Jun 2024
- Type of study
- Observational
- Treatments tested
- TAVI, pacemaker
- Record updated
- 7 August 2024
Who can take part
- Age
- 51 years to 95 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020
Who cannot take part
- previous device implantation
- patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)
- valve-in-valve procedure
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.
The group in the trial
- Patients undergoing TAVI at DHZC 2019-2021
Treatment: TAVI, pacemaker
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 7 August 2024