Completed
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis
What is being collected
Data Collection
Who is being recruted
Over 18 Years
+6 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: December 2012
Summary
Principal SponsorKlinik für Kardiologie, Pneumologie und Angiologie
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation. The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.
Principal SponsorKlinik für Kardiologie, Pneumologie und Angiologie
Last updated: November 13, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
patients screened for TAVI
symptomatic aortic valve stenosis
written informed consent
3 exclusion criteria prevent from participating
18 years
permanent pacemaker
unconsciousness, not able to consent
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, GermanyOpen Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf in Google MapsCompletedOne Study Center