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Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

NCT00356057 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-02-27

Study results available
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Summary

The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

Conditions

Interventions

DEVICE

Protos DR/CLS and Stratos LV CRT pacemakers

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Orlov, MD · Caritas Elizabeth, Boston, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-05-31
Completion
2008-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356057 on ClinicalTrials.gov