NCT01611389

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 5, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

May 31, 2012

Last Update Submit

June 4, 2012

Conditions

Sinus Node Disease.First Degree Atrioventricular Block.

Outcome Measures

Primary Outcomes (1)

  • Oxygen uptake (cardiopulmonary exercise testing).

    3 months

Secondary Outcomes (5)

  • Left ventricular ejection fraction.

    3 months

  • Quality of life

    3 months

  • Arrhythmia

    3 months

  • Ventilatory anaerobic threshold (cardiopulmonary exercise testing)

    3 months

  • VE/VCO2 slope (cardiopulmonary exercise testing).

    3 months

Study Arms (2)

Long AV delay.

EXPERIMENTAL
Device: Prolonging atrioventricular (AV) delay.

Short AV delay.

ACTIVE COMPARATOR
Device: Standard atrioventricular (AV) delay.

Interventions

Prolonging atrioventricular (AV) delay.DEVICE

Prolonging atrioventricular (AV) delay to maximum 350 ms.

Long AV delay.
Standard atrioventricular (AV) delay.DEVICE

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

Short AV delay.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • second or third degree atrioventricular block,
  • permanent atrial fibrillation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Krystian Krzyżanowski, MD

CONTACT

512 356 207krystian.krzyzanowski@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 5, 2012

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 5, 2012

Record last verified: 2012-05

Locations

PL(1)