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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01801098
First received: February 6, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition
Symptomatic Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Determination of HV interval [ Time Frame: Changes in Baseline to 24 hours ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • AV-block development after 1 month, 6 months and 12 months [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • cardiovascular mortality [ Time Frame: 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801098

Locations
Germany
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
Principal Investigator: Malte Kelm, MD Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Principal Investigator: Marc W. Merx, MD Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf
Principal Investigator: Dong-In Shin, MD Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
  More Information

Additional Information:
No publications provided

Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01801098     History of Changes
Other Study ID Numbers: HV-interval prior TAVI
Study First Received: February 6, 2013
Last Updated: November 12, 2013
Health Authority: Germany: Ethic Committee

Keywords provided by Heinrich-Heine University, Duesseldorf:
TAVI
complete AV-block
HV-interval
permanent pacemaker

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on April 20, 2014