Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Cardiac Resynchronization Therapy implant

• Registration Number: NCT00819117
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-01-07
• Study First Submitted QC: 2009-01-07
• Study First Posted: 2009-01-08
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epicardial Lead (EPI CRT)	Cardiac Resynchronization Therapy implant	Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)
Transvenous Lead (TVN CRT)	Cardiac Resynchronization Therapy implant	Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)

Primary Outcome Measures

Name	Time	Method
The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.	6 months follow up after implant

Trial Locations

Locations (2)

Ospedale Cisanello; 🇮🇹 Pisa, Italy

Azienda Sanitaria Osperaliera Ordine Mauriziano; 🇮🇹 Torino, Italy