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Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias

NCT ID: NCT01717469

Last Updated: 2012-11-06

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

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.

Detailed Description

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Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.

This randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.

Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.

Conditions

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Bradyarrhythmias Arrhythmias Atrioventricular Block Ventricular Dysfunction Cardiovascular Disease

Keywords

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Pacemaker Pacemaker implantation Coronary sinus Ventricular dysfunction Right ventricular pacing Left ventricular pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RV Pacing

Right ventricular pacing

Group Type ACTIVE_COMPARATOR

Right ventricular pacing (Medtronic)

Intervention Type DEVICE

Conventional right ventricular pacing in patients with bradycardia.

LV Pacing

Left ventricular pacing through coronary sinus tributaries

Group Type EXPERIMENTAL

Left ventricular pacing through coronary sinus tributaries (Attain StarFix)

Intervention Type DEVICE

Left ventricular pacing in patients with bradycardia

Interventions

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Left ventricular pacing through coronary sinus tributaries (Attain StarFix)

Left ventricular pacing in patients with bradycardia

Intervention Type DEVICE

Right ventricular pacing (Medtronic)

Conventional right ventricular pacing in patients with bradycardia.

Intervention Type DEVICE

Other Intervention Names

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Attain StarFix® Model 4195 OTW Lead Right ventricular lead Medtronic 5076-58

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Pacemaker initial implant by transvenous approach
* Presence of AV block
* Presence of atrial fibrillation / atrial flutter with slow ventricular response
* Left ventricular systolic function \> 0.40
* Subject agreed to participate and signed the consent form

Exclusion Criteria

* Absence of venous access
* Impediment of venous access due to presence of intracardiac defects
* Impediment of venous access due to presence of tricuspid valve prosthesis
* Need for radiotherapy in the chest
* Presence of chest deformity
* Pregnancy
* Life expectancy of less than one year
* Contraindication to administration of iodinated contrast (creatinine \> 3.0) Unable to attend the follow-up appointments
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Roberto Costa

Associated Professor of Cardiovascular Surgery, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Costa, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Roberto Costa, MD PhD

Role: CONTACT

Phone: 55-11-2661

Email: [email protected]

Katia R Silva, RN PhD

Role: CONTACT

Phone: 9195978619

Email: [email protected]

Facility Contacts

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Robeto Costa, MD PhD

Role: primary

Katia R Silva, RN PhD

Role: backup

Other Identifiers

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CAAE 00610412.2.0000.0068

Identifier Type: -

Identifier Source: org_study_id