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Role of Left Ventricular Pacing Site

NCT ID: NCT00221780

Last Updated: 2007-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-12-31

Brief Summary

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Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

Detailed Description

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Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.

Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.

Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.

Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure

Outcomes. Hemodynamic measures using pressure-volume catheters.

Conditions

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Heart Failure Cardiomyopathy, Dilated Coronary Disease

Keywords

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Heart failure Cardiomyopathy, dilated Coronary disease Cardiac Pacing, Artificial Hemodynamics Randomized Controlled Trials Single-Blind Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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left ventricular pacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Heart failure referred for cardiac resynchronization therapy
* NYHA Class III or IV
* Informed consent form signed

Exclusion Criteria

* Hypertension not controlled by treatment
* Coronary ischemia not controlled by treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Principal Investigators

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Pierre Jaïs, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Paul Perez, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

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Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor

Pessac, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Jaïs, Dr

Role: CONTACT

Phone: 33 (0) 5 57 65 64 71

Email: [email protected]

Facility Contacts

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Pierre Jaïs, Dr

Role: primary

Other Identifiers

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2001-030

Identifier Type: -

Identifier Source: secondary_id

9426-01

Identifier Type: -

Identifier Source: org_study_id