- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564173
Dependence of LV Hemodynamics on Pacing Site
January 31, 2019 updated by: Abbott Medical Devices
Characterization of LV Hemodynamics During Epicardial and Endocardial Pacing
The purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (LV) segments on cardiac hemodynamics in patients with impaired LV function undergoing epicardial ablation and mapping procedure.
Hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the LV.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France
- CHU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
Description
Inclusion Criteria:
- Patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach
- Be in sinus rhythm
- Have LVEF < 40%
- Have the ability to provide informed consent for study participation and be willing and able to comply with the CIP (Clinical Investigational Plan) described evaluations
Exclusion Criteria:
- Have permanent AF
- Have pericardial disease
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
- Have had a recent CVA or TIA within 3 months prior to enrollment
- Be less than 18 years of age
- Be pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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VT Ablation
Patients undergoing epicardial mapping and ablation procedure for a ventricular tachycardia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Invasive Dp/dt Max
Time Frame: Acute E.P. Procedure
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Variation on invasive Dp/dt max during dedicated pacing site
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Acute E.P. Procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre Jais, MD, University Hospital, Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 24, 2012
First Submitted That Met QC Criteria
March 24, 2012
First Posted (Estimate)
March 27, 2012
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
January 31, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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