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Complete AV BlockLVPACENCT01302717

Left Ventricular Pacing to Avoid Cardiac Enlargement Study

A study testing LV pacing and RV pacing in people with Complete AV Block and Sick Sinus Syndrome, run by Seoul National University Hospital at 2 sites in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Complete AV Block, Sick Sinus Syndrome
What is being tested?
LV pacing and RV pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesSouth Korea
Study dates
Apr 2010to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
  • Paced QRS duration ≥185 ms

Who cannot join

  • Left ventricular ejection fraction < 50 %
  • Acute coronary syndrome
  • If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
  • if they had a life expectancy of less than 1 year
  • if they had received a heart transplant

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam, 464-707

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients

In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.

Read the detailed description

In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.

The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.

Being tested
LV pacing, RV pacing
Keywords
Left ventricular pacing
Medical subject headings
Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LV pacingDevice

    The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.

  • RV pacingDevice

    The right ventricular lead are positioned at the right ventricular apex.

Study groups in NCT01302717
Study groupRoleWhat they receive
Right ventricular pacingActive comparatorNot described
Receives: Device: RV pacing
Left ventricular pacingExperimentalNot described
Receives: Device: LV pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction (%) at 12 months

    Measured by modified Simpson's method

    Measured: 12 months

Secondary outcomes (5)

  1. Left ventricular end-systolic volume (ml) at 12 months

    Measured by modified Simpson method

    Measured: 12 months

  2. Left ventricular end-diastolic volume (ml) at 12 months

    Measured by modified Simpson method

    Measured: 12 months

  3. NYHA functional class

    Measured: 12 months

  4. Functional capacity

    measured by treadmill test

    Measured: 12 months

  5. NT-proBNP

    plasma level

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2011 (estimated)
  2. Study startApr 2010
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Why it stopped: Difficulty in enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302717
Sponsor's protocol ID
LVPACE
Acronym
LVPACE
Status last verified
Apr 2023
First submitted
19 Feb 2011
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing LV pacing and RV pacing in people with Complete AV Block and Sick Sinus Syndrome, run by Seoul National University Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction (%) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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