Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement - Full Text View

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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, March 2010

First Received: March 4, 2010 Last Updated: August 19, 2010 History of Changes

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT01081093

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:	Primary Purpose: Treatment
Official Title:	Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Study Start Date:	April 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Biventricular pacing: Experimental	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

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

ClinicalTrials.gov Identifier:	NCT01081093 History of Changes
Other Study ID Numbers:	Bivent001AR-AHK
Study First Received:	March 4, 2010
Last Updated:	August 19, 2010
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 September 01, 2010