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Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement (BIVENT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081093
First Posted: March 5, 2010
Last Update Posted: August 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
  Purpose

Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.

A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.

The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.


Condition Intervention
Hypertrophic Cardiomyopathy Procedure: additional temporary pacewire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Cardiac output [ Time Frame: intraoperative ]

Estimated Enrollment: 72
Study Start Date: April 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biventricular pacing Procedure: additional temporary pacewire
Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years
  • Hypertrophic Cardiomyopathy
  • Aortic valve replacement

Exclusion Criteria:

  • Atrial fibrillation
  • Pericarditis
  • postoperative low output
  • Preoperative permanent pacemaker placement
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081093


Locations
Germany
Johann Wolfgang Goethe Universitätsklinikum
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01081093     History of Changes
Other Study ID Numbers: Bivent001AR-AHK
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:
Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction
Biventricular Pacemaker cardiac surgery aortic valve replacement

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases