At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 1,491 enrolled

Drug / intervention

Closed Loop Stimulation (CLS) +2 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355797

NCT00355797Phase 4Completed

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CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities

Biotronik, Inc.·interventional·Posted Jul 25, 2006·Updated Dec 20, 2012

In Brief

A Phase 4 clinical trial evaluating Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, and 1 other intervention for Bradycardia. Completed, enrolled 1,491 participants across 99 sites.

Detailed Summary

This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive technology (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBradycardia

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2006

First PostedJul 2006

Primary CompletionFeb 2008

Study CompletionDec 2010

TodayJul 2026

First PostedJul 25, 2006

Enrollment StartMay 1, 2006

Primary CompletionFeb 1, 2008

Study CompletionDec 1, 2010

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 19.9 years ago

Interventions

Closed Loop Stimulation (CLS)device

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the Closed Loop Stimulation (DDD-CLS or VVI-CLS) pacing mode for the long-term follow-up portion of this study.

Standard Rate Adaptive (R) Technologydevice

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the standard are adaptive pacing mode (DDDR or VVIR) for the long-term follow-up portion of this study.

Non-rate adaptive (DDD) pacingdevice

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the non-rate adaptive pacing mode (DDD or VVI) for the long-term follow-up portion of this study.