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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01081093
First received: March 4, 2010
Last updated: June 3, 2013
Last verified: June 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Cardiac output [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: April 2010
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01081093

Contacts
Contact: Arndt H Kiessling, MD +49 (0) 69 / 6301 ext 0

Locations
Germany
Johann Wolfgang Goethe Universitätsklinikum Recruiting
Frankfurt am Main, Germany, 60590
Contact: Arndt H Kiessling, MD    +49 (0) 69 / 6301 ext 0    arndt.kiessling@kgu.de   
Johann Wolfgang Goethe Universitätsklinikum Recruiting
Frankfurt am Main, Germany, 60590
Contact: Arndt H Kiessling, MD    +49 69 6301 ext 87015    arndt.kiessling@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Arndt-H. Kiessling, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01081093     History of Changes
Other Study ID Numbers: Bivent001AR-AHK
Study First Received: March 4, 2010
Last Updated: June 3, 2013
Health Authority: Germany: Ethikkommission Frankfurt am Main

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Hypertrophic Cardiomyopathy Diastolic Ventricular Interaction
Biventricular Pacemaker cardiac surgery aortic valve replacement

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

ClinicalTrials.gov processed this record on July 26, 2014