Cardiac PacingORVFUPNCT00949715

Optimize RV Follow-up Selective Site Pacing Clinical Trial

A study testing Medtronic or Vitatron Dual-Chamber Pacemaker and Medtronic SelectSecure 3830 Lead in people with Cardiac Pacing and Right Ventricular Pacing, run by Medtronic Cardiac Rhythm and Heart Failure at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the Optimize RV Follow-Up 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 selective site pacing is to improve how the heart contracts when paced. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
What is being tested?: Medtronic or Vitatron 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: 67 participants
Where: 12 sitesin 3 countries
Study dates: Sep 2009to Dec 2011
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 enrolled in the Optimize RV study (version 3, dated 6 March 2007)
Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)

Who cannot join

Subjects who have a device that was programmed outside the Optimize RV programming requirements
Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Subjects who are pregnant or nursing

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

United States10 sites

Study site
Burlington, Vermont
Study site
Cleveland, Ohio
Study site
Des Moines, Iowa
Study site
Fort Worth, Texas
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Saint Paul, Minnesota
Study site
Silver Spring, Maryland
Study site
Southfield, Michigan
Study site
Tomball, Texas

Other trials in United States

Israel1 site

Study site
Ramat Gan

Other trials in Israel

Italy1 site

Study site
Rovigo

Other trials in Italy

About this study

Read the detailed description

The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.

Conditions: Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
Being tested: Medtronic or Vitatron Dual-Chamber Pacemaker, Medtronic SelectSecure 3830 Lead
Keywords: Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Selective Site Pacing

What participants receive

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

Medtronic or Vitatron Dual-Chamber PacemakerDevice
A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability
Medtronic SelectSecure 3830 LeadDevice
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

Study groups in NCT00949715
Study group	Role	What they receive
RV Mid-Septal Pacing	Active comparator	Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart Receives: Device: Medtronic or Vitatron Dual-Chamber Pacemaker; Device: Medtronic SelectSecure 3830 Lead
RV Apical Pacing	Active comparator	Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex Receives: Device: Medtronic or Vitatron 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.

Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month
Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view
Measured: 24 months

Secondary outcomes (3)

Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.
Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.
Measured: 24 months
Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.
Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.
Measured: 24 months
Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.
Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.
Measured: Whole time from baseline to 24 months averaged by day

Timeline

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

Sep 2009Dec 2011

First posted30 Jul 2009 (estimated)
Study startSep 2009
Primary completionApr 2011
Study completionDec 2011

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 PacingStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00949715
Sponsor's protocol ID: Optimize RV Follow-Up
Acronym: ORVFUP
Status last verified: Jan 2018
First submitted: 28 Jul 2009
Last updated: 15 Feb 2018
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

RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block

All Cardiac Pacing trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimize RV Follow-up Selective Site Pacing Clinical Trial
ClinicalTrials.gov ID: NCT00949715
Acronym / sponsor ID: ORVFUP / Optimize RV Follow-Up
Conditions: Cardiac Pacing, Right Ventricular Pacing, Left Ventricular Ejection Fraction
Keywords: Pacemaker, Implantable Pulse Generator (IPG), AV Conduction Disturbance, Selective Site Pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Apr 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 30 Jul 2009 (estimated)
Results: Posted 1 Oct 2013

Clinical summary

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

Detailed description

The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RV Mid-Septal Pacing	Active comparator	Device: Medtronic or Vitatron Dual-Chamber Pacemaker, Device: Medtronic SelectSecure 3830 LeadPacing lead located 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 or Vitatron Dual-Chamber Pacemaker, Device: Medtronic SelectSecure 3830 LeadPacing lead located 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 (2 listed)

Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007)
Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)

Key exclusion criteria (3 listed)

Subjects who have a device that was programmed outside the Optimize RV programming requirements
Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Subjects who are pregnant or nursing

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 or Vitatron Dual-Chamber PacemakerA Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability	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

Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month
Time frame: 24 months
Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view

3 secondary outcomes

Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.
Time frame: 24 months
Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.
Time frame: 24 months
Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.
Time frame: Whole time from baseline to 24 months averaged by day

Results and safety

Results posted to the registry on 1 Oct 2013, 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 Apical Pacing	32	28
RV Mid-Septal Pacing	33	33

Primary outcome: Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month

Time frame: 24 months. Mean (95% Confidence Interval). Unit: percentage of LVEF

Measure	RV Apical Pacing n = 28	RV Mid-Septal Pacing n = 33
Value	48.3 (43.7 to 53.0)	51.2 (46.5 to 56.0)

RV Apical Pacing vs RV Mid-Septal Pacing: Mean Difference (Final Values): 4.0 (95% CI -2.7 to 10.8), p = 0.2352, t-test, 2 sided

Population analysed: Subjects who had LVEF measurements from both baseline and 24 month timepoints

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Subjects	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Since the enrollment goal of the study (n=160) was not met (it was decided to stop enrollments after 67 due to slow enrollments), the results of the study were not powered and the results for the primary objective are inconclusive at this time.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiac Pacing

RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
Heart Failure - NYHA II - IV
Recruiting
ELEVATE-HFpEF Clinical Study
Heart Failure With Preserved Ejection Fraction (HFpEF)
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block

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 Follow-Up Team study chair

Medtronic

12 sites in 3 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Israel, Italy. 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 Oct 2013). 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?

Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month (time frame: 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 NCT00949715.

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 15 Feb 2018.