Minimizing Ventricular Pacing

NCT ID: NCT01611389

Last Updated: 2012-06-05

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-12-31

Brief Summary

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The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.

Detailed Description

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Conditions

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Sinus Node Disease. First Degree Atrioventricular Block.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long AV delay.

Group Type EXPERIMENTAL

Prolonging atrioventricular (AV) delay.

Intervention Type DEVICE

Prolonging atrioventricular (AV) delay to maximum 350 ms.

Short AV delay.

Group Type ACTIVE_COMPARATOR

Standard atrioventricular (AV) delay.

Intervention Type DEVICE

Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.

Interventions

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Prolonging atrioventricular (AV) delay.

Prolonging atrioventricular (AV) delay to maximum 350 ms.

Intervention Type DEVICE

Standard atrioventricular (AV) delay.

Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* prolonged PQ interval \> 200 ms,
* percentage of right ventricular pacing with standard AV delay \> 90.

Exclusion Criteria

* second or third degree atrioventricular block,
* permanent atrial fibrillation.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Locations

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Military Institute of Medicine

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Krystian Krzyżanowski, MD

Role: CONTACT

512 356 207 ext. 48

Other Identifiers

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N N402 533539

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

83562

Identifier Type: -

Identifier Source: org_study_id

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