Cardiac Pacing, ArtificialNCT00422669

Optimize RV Selective Site Pacing Clinical Trial

A study testing Medtronic Dual-Chamber Pacemaker and Medtronic SelectSecure 3830 Lead in people with Cardiac Pacing, Artificial and Cardiac Pacemaker, Artificial, run by Medtronic Cardiac Rhythm and Heart Failure at 22 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
What is being tested?: Medtronic Dual-Chamber Pacemaker and Medtronic SelectSecure 3830 Lead
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 22 sitesin 6 countries
Study dates: Jan 2007to May 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
Subjects greater than 18 yrs of age
Subjects that are indicated for a dual chamber pacemaker
Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Who cannot join

Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
Subjects indicated for an implantable cardiac defibrillator (ICD)
Subjects with permanent atrial fibrillation (AF)
Subjects with expected managed ventricular pacing turned on
Subjects with a previously implanted pacemaker, ICD, or CRT device
Subjects with an myocardial infarction (MI) within 3 months prior to enrollment

Show all 14Show fewer

Subjects that received bypass surgery within 3 months prior to enrollment
Subjects that had valve replacement within 3 months prior to enrollment
Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
Subjects with a mechanical right heart valve
Women who are pregnant or nursing
Significant co-morbidity preventing study completion
Terminal conditions with a life expectancy of less than two years
Participation in another study that would confound the results of this study

Trial locations and contacts

22 sites in 6 countries.

Country

City, postcode or hospital

22 sites in 6 countries

United States16 sites

Study site
Bridgeport, Connecticut
Study site
Burlington, Vermont
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Des Moines, Iowa
Study site
Fort Worth, Texas
Study site
Hudson, Florida
Study site
Nashville, Tennessee
Study site
Omaha, Nebraska
Study site
Saint Paul, Minnesota
Study site
Salt Lake City, Utah
Study site
Silver Spring, Maryland
Study site
Southfield, Michigan
Study site
Takoma Park, Maryland
Study site
Tomball, Texas

Other trials in United States

Italy2 sites

Study site
Florence
Study site
Rovigo

Other trials in Italy

Canada1 site

Study site
Montreal

Other trials in Canada

China1 site

Study site
Hong Kong

Other trials in China

Israel1 site

Study site
Ramat Gan

Other trials in Israel

Qatar1 site

Study site
Doha

Other trials in Qatar

About this study

Conditions: Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Being tested: Medtronic Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
Keywords: Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Select Site Pacing

What participants receive

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

Medtronic Dual-Chamber PacemakerDevice
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Medtronic SelectSecure 3830 LeadDevice
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Study groups in NCT00422669
Study group	Role	What they receive
RV Mid-Septal Pacing	Active comparator	Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart Receives: Device: Medtronic Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead
RV Apical Pacing	Active comparator	Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex Receives: Device: Medtronic Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead

What is being measured

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

The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Measured: Baseline and 24 months

Secondary outcomes (5)

The Change in LVEF From Two Week Visit to Two Year Follow-up
Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Measured: Baseline and 24 months
The Change in Six-minute Hall Walk Distance
The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.
Measured: Baseline and 24 months
The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up
LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).
Measured: Baseline and 24 months
Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up
Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.
Measured: Baseline and 24 months
Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up
Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.
Measured: Baseline and 24 months

Timeline

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

Jan 2007May 2009

First posted17 Jan 2007 (estimated)
Study startJan 2007
Primary completionMay 2009
Study completionMay 2009

Why it stopped: Study enrollment significantly below protocol expectations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac Pacing, ArtificialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Participant
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00422669
Sponsor's protocol ID: 604
Status last verified: Jan 2013
First submitted: 12 Jan 2007
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BIO|MASTER.CSP Study
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Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
Bradycardia, Atrioventricular Block
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RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
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RecruitingObservational study
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
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All Cardiac Pacing, Artificial trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimize RV Selective Site Pacing Clinical Trial
ClinicalTrials.gov ID: NCT00422669
Acronym / sponsor ID: 604
Conditions: Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Keywords: Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Select Site Pacing
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study enrollment significantly below protocol expectations
Enrolment: 205 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 17 Jan 2007 (estimated)
Results: Posted 1 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
RV Mid-Septal Pacing	Active comparator	Device: Medtronic Dual-Chamber Pacemaker, Device: Medtronic SelectSecure 3830 LeadPacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
RV Apical Pacing	Active comparator	Device: Medtronic Dual-Chamber Pacemaker, Device: Medtronic SelectSecure 3830 LeadPacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
Subjects greater than 18 yrs of age
Subjects that are indicated for a dual chamber pacemaker
Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Key exclusion criteria (14 listed)

Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
Subjects indicated for an implantable cardiac defibrillator (ICD)
Subjects with permanent atrial fibrillation (AF)
Subjects with expected managed ventricular pacing turned on
Subjects with a previously implanted pacemaker, ICD, or CRT device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic Dual-Chamber PacemakerA Medtronic market-approved dual-chamber implantable pulse generator (IPG)	Device	RV Apical Pacing, RV Mid-Septal Pacing
Medtronic SelectSecure 3830 LeadMedtronic market-approved SelectSecure Model 3830 bipolar pacing lead	Device	RV Apical Pacing, RV Mid-Septal Pacing

Primary outcome

The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
Time frame: Baseline and 24 months
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.

5 secondary outcomes

The Change in LVEF From Two Week Visit to Two Year Follow-up
Time frame: Baseline and 24 months
The Change in Six-minute Hall Walk Distance
Time frame: Baseline and 24 months
The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up
Time frame: Baseline and 24 months
Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up
Time frame: Baseline and 24 months
Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up
Time frame: Baseline and 24 months

Results and safety

Results posted to the registry on 1 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RV Mid-Septal Pacing	98	0
RV Apical Pacing	100	0
Not Randomized	7	0

Primary outcome: The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up

Time frame: Baseline and 24 months

Population analysed: Data required for the analysis were not collected due to early study termination. Analysis will not be done.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events reported before the study termination were included.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Implant	50 of 198 (25.3%)	12 of 198 (6.1%)	Not reported

Limitations and caveats (from the sponsor): Early study termination due to enrollment rates significantly below protocol expectations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiac Pacing, Artificial

Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Not yet recruiting
Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
Bradycardia, Atrioventricular Block
Recruiting
AI-Guided Left Bundle Branch Area Pacing
Heart Failure
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Optimize RV Team study chair

Medtronic

22 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Italy, Canada, China, Israel and 1 more country. 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?

Yes. Results are posted in the registry (first posted 1 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up (time frame: Baseline and 24 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 NCT00422669.

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 31 Jan 2013.