Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response (CLEAR)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biotronik, Inc.

ClinicalTrials.gov Identifier:

NCT00355797

First received: July 21, 2006

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Results First Received: June 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Bradycardia
Interventions:	Device: Closed Loop Stimulation (CLS) Device: Standard Rate Adaptive (R) Technology Device: Non-rate adaptive (DDD) pacing

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CLS Rate Adaptive Pacing	Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
Standard Rate Adaptive Pacing	Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
No Rate Adaptive Pacing	Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.

Participant Flow: Overall Study

	CLS Rate Adaptive Pacing	Standard Rate Adaptive Pacing	No Rate Adaptive Pacing
STARTED	741	369	381
COMPLETED	501	221	239
NOT COMPLETED	240	148	142

Baseline Characteristics

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Reporting Groups

	Description
CLS Rate Adaptive Pacing	Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
Standard Rate Adaptive Pacing	Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
No Rate Adaptive Pacing	Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
Total	Total of all reporting groups

Baseline Measures

	CLS Rate Adaptive Pacing	Standard Rate Adaptive Pacing	No Rate Adaptive Pacing	Total
Number of Participants [units: participants]	741	369	381	1491
Age [units: years] Mean ± Standard Deviation	73.5 ± 11.7	72.5 ± 12.0	72.7 ± 12.4	73.1 ± 12.0
Gender [units: participants]
Female	308	178	190	676
Male	433	191	191	815

Outcome Measures

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1. Primary:

Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) [ Time Frame: within 45 days of enrollment ]

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2. Primary:

Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test) [ Time Frame: within 45 days of enrollment ]

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3. Secondary:

Change in Quality of Life [ Time Frame: baseline and 12 months ]

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4. Secondary:

Mode Reprogramming [ Time Frame: 12 months ]

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5. Secondary:

Atrial Fibrillation (AF) Burden [ Time Frame: 12 months ]

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Measure Type	Secondary
Measure Title	Atrial Fibrillation (AF) Burden
Measure Description	AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.
Time Frame	12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Percentage of atrial burden was collected for subjects utilizing dual chamber pacing that completing a 12-month follow-up visit.

Reporting Groups

	Description
CLS Rate Adaptive Pacing	Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
Standard Rate Adaptive Pacing	Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
No Rate Adaptive Pacing	Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.

Measured Values

	CLS Rate Adaptive Pacing	Standard Rate Adaptive Pacing	No Rate Adaptive Pacing
Number of Participants Analyzed [units: participants]	409	183	212
Atrial Fibrillation (AF) Burden [units: percentage of atrial beats] Mean ± Standard Deviation	7.54 ± 20.75	5.57 ± 16.81	6.65 ± 19.86

No statistical analysis provided for Atrial Fibrillation (AF) Burden

6. Secondary:

Cardiac Symptoms [ Time Frame: 12 months ]

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7. Secondary:

Change in New York Heart Association (NYHA) Class [ Time Frame: baseline and 12 months ]

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8. Secondary:

Change in 6-minute Walk Test Distance [ Time Frame: baseline and 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: CLEAR Study CSE
Organization: BIOTRONIK, Inc.
phone: 503-451-8051

No publications provided

Responsible Party:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00355797 History of Changes
Other Study ID Numbers:	20060536
Study First Received:	July 21, 2006
Results First Received:	June 6, 2011
Last Updated:	December 18, 2012
Health Authority:	United States: Institutional Review Board

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