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Register:	ClinicalTrials.gov
Last refreshed on:	9 January 2017
Main ID:	NCT03008096
Date of registration:	16/12/2016
Prospective Registration:	No
Primary sponsor:	Philipp Angleitner
Public title:	Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients LSG-BTC-LVAD
Scientific title:	Laparoscopic Sleeve Gastrectomy as Bridge-to-Candidacy for Obese Left-Ventricular Assist Device Patients
Date of first enrolment:	November 2016
Target sample size:	10
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03008096
Study type:	Interventional
Study design:	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Philipp Angleitner, Dr.
Address:
Telephone:	+4314040052620
Email:	philipp.angleitner@meduniwien.ac.at
Affiliation:

Name:	Philipp Angleitner, Dr.
Address:
Telephone:	+4314040052620
Email:	philipp.angleitner@meduniwien.ac.at
Affiliation:

Name:	Daniel Zimpfer, Priv.-Doz. Dr.
Address:
Telephone:
Email:
Affiliation:	Medical University of Vienna

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ambulatory patients on LVAD-support for end-stage heart failure

- Bridge-to-Candidacy strategy

- BMI > 35kg/m2

- Failure to reach BMI < 30kg/m2 with conservative measures

- Age > 18 years

- Ability to give informed consent

Exclusion Criteria:

- Absolute contraindications to subsequent heart transplantation other than obesity

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Heart Failure

Intervention(s)

Procedure: Laparoscopic Sleeve Gastrectomy

Primary Outcome(s)

BMI (Body-Mass-Index) [Time Frame: 12 months post-LSG]

Secondary Outcome(s)

6-min Walking Test [Time Frame: 12 months post-LSG]

LVEF (Left-Ventricular Ejection Fraction) [Time Frame: 12 months post-LSG]

NYHA (New York Heart Association) Class [Time Frame: 12 months post-LSG]

EQ-5D (EuroQol five dimensions) questionnaire [Time Frame: 12 months post-LSG]

Severe adverse events [Time Frame: 12 months post-LSG]

WHOQOL-BREF (World Health Organization Quality of Life) questionnaire [Time Frame: 12 months post-LSG]

VO2 max (maximum rate of oxygen consumption) [Time Frame: 12 months post-LSG]

Work Ability questionnaire [Time Frame: 12 months post-LSG]

Secondary ID(s)

LSG-BTC-LVAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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