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

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ClinicalTrials.gov Identifier: NCT01081093
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hypertrophic Cardiomyopathy Procedure: additional temporary pacewire

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement
Study Start Date : April 2010
Primary Completion Date : August 2014
Study Completion Date : August 2014


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Cardiac output [ Time Frame: intraoperative ]

Eligibility Criteria

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 Posted: March 5, 2010    Key Record Dates
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