Late Complication From Cardiac Pacemaker ImplantationNCT01682239

Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI

A study testing RVAP and RVSP in people with Late Complication From Cardiac Pacemaker Implantation, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Late Complication From Cardiac Pacemaker Implantation
What is being tested?: RVAP and RVSP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteAustria
Study dates: Sep 2012to Aug 2015
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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with dysrhythmia requiring dual-chamber pacemaker implantation
planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
age between 18-90 years
no absolute pacemaker dependence
no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH <15mm, LV EF>50%)
no previous myocardial infarction or significant coronary artery disease
life expectancy > 1 year
patients willing to participate in follow-up

Who cannot join

Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
Any contraindication for surgery
Absolute pacemaker dependence
Claustrophobia
GFR<30ml/min/1,73m2
Allergy to contrast agent

Trial locations and contacts

1 site in 1 country.

Austria1 site

Department of Cardiac Surgery, MUV
Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Official title: Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial

Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors. An important factor seems to be optimal lead positioning. Data regarding left ventricular function impaired by lead positioning is insufficient. The aim of the present study therefore is to compare right ventricular apical pacing (RVAP) with right ventricular septal pacing (RVSP). Outcome measurements are echocardiographic features, magnetic resonance imaging and clinical outcome.

Conditions: Late Complication From Cardiac Pacemaker Implantation
Being tested: RVAP, RVSP

What participants receive

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

RVAPOther
In this arm pacemaker leads will be placed in the RV apex.
RVSPOther
In this arm pacemaker leads will be placed in the RV septum.

Study groups in NCT01682239
Study group	Role	What they receive
RVAP lead	Experimental	Pacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy. Receives: Other: RVAP
RVSP arm	Experimental	Pacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy. Receives: Other: RVSP

What is being measured

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

Ejection Fraction
As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.
Measured: 6 month

Timeline

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

Sep 2012Aug 2015

First posted10 Sep 2012 (estimated)
Study startSep 2012
Primary completionAug 2014 (estimated)
Study completionAug 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Late Complication From Cardiac Pacemaker ImplantationStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682239
Sponsor's protocol ID: EC 023/2012
Status last verified: Sep 2012
First submitted: 6 Sep 2012
Last updated: 10 Sep 2012
Results posted: No
Data monitoring committee: Yes

Publications

Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2.
PubMed 22851216
Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30.
PubMed 20451689
Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20.
PubMed 21597204

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Different Right Ventricular Lead Positioning on Cardiac Contraction Measured by Cardiac MRI: a Pilot Trial
ClinicalTrials.gov ID: NCT01682239
Acronym / sponsor ID: EC 023/2012
Conditions: Late Complication From Cardiac Pacemaker Implantation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: Sep 2012
Primary completion: Aug 2014 (estimated)
Study completion: Aug 2015 (estimated)
First posted: 10 Sep 2012 (estimated)
Results: Not posted in the source record

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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
RVAP lead	Experimental	Other: RVAPPacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV apex. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.
RVSP arm	Experimental	Other: RVSPPacemaker lead implantation: Pacemaker leads will be placed in specific predefined RA and RV sites according to randomization. In this arm pacemaker leads will be placed in the RV septum. The successful lead positioning at its target location will be verified by surface ECG and by fluoroscopy.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

patients with dysrhythmia requiring dual-chamber pacemaker implantation
planed MRI-pacemaker implantation (Accent MRI System,St. Jude Medical)
age between 18-90 years
no absolute pacemaker dependence
no present heart failure or any significant coronary heart disease (exclusion by anamnesis and echocardiography - LVH <15mm, LV EF>50%)

Key exclusion criteria (6 listed)

Contraindications for MRI (Brain aneurysm clips, artificial heart valves, artificial joints, vascular stents)
Any contraindication for surgery
Absolute pacemaker dependence
Claustrophobia
GFR<30ml/min/1,73m2

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
RVAPIn this arm pacemaker leads will be placed in the RV apex.	Other	RVAP lead
RVSPIn this arm pacemaker leads will be placed in the RV septum.	Other	RVSP arm

Primary outcome

Ejection Fraction
Time frame: 6 month
As primary endpoint the difference of ventricular function in both groups will be taken. Therefore the Ejection Fraction is measured in cardiac MRI and Echocardiography. There may be a different development of contraction, whether the lead is placed in the ventricular apex or the ventricular septum.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Background: PubMed 22851216Beinart R, Nazarian S. MRI-Conditional Cardiac Implantable Electronic Devices: What's New and What Can We Expect in the Future? Curr Treat Options Cardiovasc Med. 2012 Oct;14(5):558-64. doi: 10.1007/s11936-012-0197-2.
Background: PubMed 20451689Cano O, Osca J, Sancho-Tello MJ, Sanchez JM, Ortiz V, Castro JE, Salvador A, Olague J. Comparison of effectiveness of right ventricular septal pacing versus right ventricular apical pacing. Am J Cardiol. 2010 May 15;105(10):1426-32. doi: 10.1016/j.amjcard.2010.01.004. Epub 2010 Mar 30.
Background: PubMed 21597204Inoue K, Okayama H, Nishimura K, Saito M, Yoshii T, Hiasa G, Sumimoto T, Inaba S, Suzuki J, Ogimoto A, Funada J, Higaki J. Right ventricular septal pacing preserves global left ventricular longitudinal function in comparison with apical pacing: analysis of speckle tracking echocardiography. Circ J. 2011;75(7):1609-15. doi: 10.1253/circj.cj-10-1138. Epub 2011 May 20.

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.

Alfred Kocher, MD principal investigator

Department of Cardiac Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RVAP and RVSP in people with Late Complication From Cardiac Pacemaker Implantation, run by Medical University of Vienna at 1 site in Austria.

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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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?

Results are not available in the source record.

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?

Ejection Fraction (time frame: 6 month). 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 NCT01682239, which also lists 3 linked publications.

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 10 Sep 2012.