Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

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Detailed Description

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This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy.

After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups:

* Control group: resynchronization via a transvenous left ventricular lead (TVN CRT);
* Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT).

All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads.

Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Transvenous Lead (TVN CRT)

Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)

Group Type ACTIVE_COMPARATOR

Cardiac Resynchronization Therapy implant

Intervention Type DEVICE

Device implant with appropriate leads

Epicardial Lead (EPI CRT)

Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)

Group Type EXPERIMENTAL

Cardiac Resynchronization Therapy implant

Intervention Type DEVICE

Device implant with appropriate leads

Interventions

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Cardiac Resynchronization Therapy implant

Device implant with appropriate leads

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
* Have a stable pharmacological therapy.

Exclusion Criteria

* Have a contra-indication to general anesthesia;
* Have a scheduled cardiac surgery;
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
* Have a life expectancy of less than 6 months;
* Are unable to provide informed consent;
* Are unable to comply with the follow-up schedule and tests;
* Are minor (age below 18 years);
* Are pregnant or are planning for pregnancy in the next 6 months.

Eligible Sex

ALL

Accepts Healthy Volunteers

No