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Clinical Trials/NCT01801098
NCT01801098
Completed
Not Applicable

Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

Klinik für Kardiologie, Pneumologie und Angiologie1 site in 1 country25 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Symptomatic Aortic Valve Stenosis
Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Enrollment
25
Locations
1
Primary Endpoint
Determination of HV interval
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible Party
Sponsor Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

Inclusion Criteria

  • symptomatic aortic valve stenosis
  • patients screened for TAVI
  • written informed consent

Exclusion Criteria

  • unconsciousness, not able to consent
  • \< 18 years
  • permanent pacemaker

Outcomes

Primary Outcomes

Determination of HV interval

Time Frame: Changes in Baseline to 24 hours

HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation.

Secondary Outcomes

  • AV-block development after 1 month, 6 months and 12 months(1 month, 6 months and 12 months)

Study Sites (1)

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