Skip to main content
OpenTrials
Completed

NCT Number: NCT01801098

Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Symptomatic Aortic Valve Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  1. AV-block development after 1 month, 6 months and 12 months

    Time frame: 1 month, 6 months and 12 months

Other outcomes

  1. cardiovascular mortality

    Time frame: 1 month, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.