Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

Randomized Study of Endovascular Versus Epicardial Lead Placement for Resynchronization Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01302470

Acronym

REVERT

Enrollment

Registered

2011-02-24

Start date

2005-02-28

Completion date

2012-03-31

Last updated

2015-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Resynchronization Therapy, Heart Failure

Keywords

biventricular pacing

Brief summary

The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

Detailed description

A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Interventions

PROCEDUREPrimary epicardial placement of left ventricular lead

Epicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device

PROCEDURETransvenous placement of left ventricular lead

Conventional placement of left ventricular leads performed in the electrophysiology department.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure * QRS interval greater than or equal to 130 msec * Left ventricular end diastolic diameter greater than or equal to 55 mm * left ventricular ejection fraction less than or equal to 35 * Willingness to participate

Exclusion criteria

* Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection * untreated active infection * acute stroke * severe uncontrolled systemic hypertension * severe systemic electrolyte imbalance * severe concomitant illness that drastically shortens life expectancy * severe coagulopathy * history of severe COPD and inability to tolerate single lung ventilation * History of prior left sided thoracotomy * history of recent intravenous drug use * concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol * participation in another investigational protocol

Design outcomes

Primary

Measure	Time frame	Description
CHF Hospitalizations & mortality	one year post implant.	Heart failure and mortality will be assesd along with six minute hall walk tests

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026