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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014