BradycardiaNCT01647490
Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position
A study testing Permanent Cardiac Pacemaker Implantation in people with Bradycardia and Heart Block, run by Ospedale Santa Maria di Loreto Mare at 2 sites in Italy.
Trial summary
This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an alternative pacing site through measures of dyssynchrony in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Heart Block, Sick Sinus Syndrome
- What is being tested?
- Permanent Cardiac Pacemaker Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2012to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for a dual chambers cardiac pacemaker device (DDD/DR) according to current guidelines
- Patients who are able to understand and sign an informed written consent
- Patients who will conduct the follow-up in the center for at least 24 months
- Patients age ≥ 18
Who cannot join
- Patients with chronic atrial fibrillation or atrial arrhythmias not controlled within 90 days before enrollment
- Pre-existing permanent cardiac pacemaker (PM), defibrillator (ICD) or cardiac resynchronization therapy device (CRT)
- Unplanned or emergency access to the hospital and / or inability to measure the dyssynchrony for the absence of spontaneous rhythm
- Patients participating in other studies that clearly impact the clinical practice of the center or whose protocol would conflict or affect the outcome of this study
- Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero Universitaria "Vittorio Emanuele"
Catania, 95124
Valeria Calvi, MD, valcalvi@unict.it
Valeria Calvi, MD
- Recruiting
Ospedale Santa Maria di Loreto Mare
Naples, 80142
Carmine Muto, MD, carminemuto@libero.it
Carmine Muto, MD
About this study
Official title: Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position - Right Pace Study
This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an alternative pacing site through measures of dyssynchrony in acute and chronic.
Read the detailed description
Permanent cardiac pacing plays an important role in cardiac disease management. Since early studies on right ventricular pacing, apex has been the preferred implant site for transvenous endocardial ventricular leads for several reasons: ease of placement, lead stability as well as the design characteristics of the electrode and the fixation system.
It is now also accepted, however, that right ventricle pacing causes a long term deterioration of left ventricular function through complex effects, both at the structural level of the heart wall and at the hemodynamic level in left ventricular load conditions. It is possible that this deterioration is due to a dyssynchrony of contraction induced by pacing at the right ventricular apex. Some authors suggest to pace the right ventricle at alternative sites, i.e. the medium septum (RVS) region, to guarantee a more physiological activation pattern, especially in patients expected to receive high pacing percentages.
However, unequivocal evidences that stimulation of the right ventricular septum is more physiological than the apical pacing are still missing.
Nonetheless, it should be noted that, although a number of studies refer to RV septum as the alternative site for pacing , poor attention has been paid to the unambiguous definition of RV septum region itself. A clear definition and a proper evaluation of the alternative site is therefore important.
Furthermore, from a procedural point of view, it has been demonstrated that acute and chronic electrical performances of the leads positioned at alternative sites, in particular in the region of mid septum, are equivalent to those of the leads positioned at the apical site.
The purpose of this study is to perform a comprehensive assessment of the electrical and mechanical measures obtained by pacing standard RV site (Right ventricular apex, RVA) and alternative RV site (right ventricular septum, RVS). Specifically, the two pacing sites will be compared in terms of electrical dyssynchrony, as assessed by ECG criteria, and in terms of mechanical dyssynchrony, as assessed by echocardiographic criteria.
The primary end point of the study is defined through the evaluation of dyssynchrony measured both in spontaneous rhythm (Vs) and paced rhythm (Vp). The delay between the time to peak systolic velocity of the septum and the LV free wall will be used to define the degree of dyssynchrony; this measurement will be obtained by TDI echocardiographic technique.
Patients will receive any commercially available dual-chamber implantable pacemakers, according to current standard indications. At the end of the implantation and at follow-up visits (12 and 24 months) device programming will follow the clinical practice of the center.
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome
- Being tested
- Permanent Cardiac Pacemaker Implantation
- Medical subject headings
- Bradycardia, Heart Block, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Cardiac Pacemaker ImplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Right Ventricular Apex (RVA) | Active comparator | In the RVA group the right ventricular pacing lead will be implanted in the apex region of the right ventricle Receives: Procedure: Permanent Cardiac Pacemaker Implantation |
| Right Ventricular Septum (RVS) | Experimental | In the RVS group the right ventricular pacing lead will be implanted in the septal region (mid septum) of the right ventricle Receives: Procedure: Permanent Cardiac Pacemaker Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV dyssynchrony as measured by Electromechanical delay (EMD
The primary outcome measure of this study is to compare the effect of RV Septal (RVS) versus RV Apical (RVA) pacing as measured by echocardiographic/Doppler Index
Measured: 2 weeks
Secondary outcomes (6)
Number of heart failure-related hospitalization
To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
Measured: 24 months
Right ventricular lead and total implant procedure time, fluoroscopy time
To compare the procedural time of RVS versus RVA pacing
Measured: Implant
Change from baseline in R wave in 12-lead ECG
To investigate the relationship between the ECG characteristics at baseline and response to cardiac pacing (as measured by echocardiography as defined in primary outcome measure) at implant and 24 months
Measured: 24 months
Absolute change in LVEF
To evaluate the Left ventricular diastolic and systolic function as measured by Echocardiographic response of absolute change in LVEF
Measured: 24 months
LV dyssynchrony as measured by Electromechanical delay (EMD)
The secondary outcome measure of this study is to compare the effect of RVS versus RVA pacing as measured by echocardiographic/Doppler Index. This extends to 24 months the results obtained with the primary objective at 2 weeks
Measured: 24 months
Symptoms and quality of life scores
To investigate the relationship between the right ventricular lead position and response to cardiac pacing in terms of symptoms and quality of life scores as measured by short form (SF)-12 scores
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria di Loreto Mare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmine Muto, Ospedale Santa Maria di Loreto Mare
- Investigators
- Carmine Muto, MD, Study chair, Ospedale Santa Maria di Loreto MareValeria Calvi, MD, Study chair, Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647490
- Sponsor's protocol ID
- LM-003
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Muto C, Calvi V, Botto GL, Pecora D, Porcelli D, Costa A, Ciaramitaro G, Airo Farulla R, Rago A, Calvanese R, Baratto MT, Reggiani A, Giammaria M, Patane S, Campari M, Valsecchi S, Maglia G. Chronic Apical and Nonapical Right Ventricular Pacing in Patients with High-Grade Atrioventricular Block: Results of the Right Pace Study. Biomed Res Int. 2018 May 22;2018:1404659. doi: 10.1155/2018/1404659. eCollection 2018.
PubMed 29951525Muto C, Calvi V, Botto GL, Pecora D, Ciaramitaro G, Valsecchi S, Malacrida M, Maglia G. Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial. Contemp Clin Trials. 2014 Nov;39(2):320-6. doi: 10.1016/j.cct.2014.10.006. Epub 2014 Oct 22.
PubMed 25465496
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position - Right Pace Study
- ClinicalTrials.gov ID
- NCT01647490
- Acronym / sponsor ID
- LM-003
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Ospedale Santa Maria di Loreto MareUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 23 Jul 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.
This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an alternative pacing site through measures of dyssynchrony in acute and chronic.
Detailed description
Permanent cardiac pacing plays an important role in cardiac disease management. Since early studies on right ventricular pacing, apex has been the preferred implant site for transvenous endocardial ventricular leads for several reasons: ease of placement, lead stability as well as the design characteristics of the electrode and the fixation system.
It is now also accepted, however, that right ventricle pacing causes a long term deterioration of left ventricular function through complex effects, both at the structural level of the heart wall and at the hemodynamic level in left ventricular load conditions. It is possible that this deterioration is due to a dyssynchrony of contraction induced by pacing at the right ventricular apex. Some authors suggest to pace the right ventricle at alternative sites, i.e. the medium septum (RVS) region, to guarantee a more physiological activation pattern, especially in patients expected to receive high pacing percentages.
However, unequivocal evidences that stimulation of the right ventricular septum is more physiological than the apical pacing are still missing.
Nonetheless, it should be noted that, although a number of studies refer to RV septum as the alternative site for pacing , poor attention has been paid to the unambiguous definition of RV septum region itself. A clear definition and a proper evaluation of the alternative site is therefore important.
Furthermore, from a procedural point of view, it has been demonstrated that acute and chronic electrical performances of the leads positioned at alternative sites, in particular in the region of mid septum, are equivalent to those of the leads positioned at the apical site.
The purpose of this study is to perform a comprehensive assessment of the electrical and mechanical measures obtained by pacing standard RV site (Right ventricular apex, RVA) and alternative RV site (right ventricular septum, RVS). Specifically, the two pacing sites will be compared in terms of electrical dyssynchrony, as assessed by ECG criteria, and in terms of mechanical dyssynchrony, as assessed by echocardiographic criteria.
The primary end point of the study is defined through the evaluation of dyssynchrony measured both in spontaneous rhythm (Vs) and paced rhythm (Vp). The delay between the time to peak systolic velocity of the septum and the LV free wall will be used to define the degree of dyssynchrony; this measurement will be obtained by TDI echocardiographic technique.
Patients will receive any commercially available dual-chamber implantable pacemakers, according to current standard indications. At the end of the implantation and at follow-up visits (12 and 24 months) device programming will follow the clinical practice of the center.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Ventricular Apex (RVA) | Active comparator | Procedure: Permanent Cardiac Pacemaker ImplantationIn the RVA group the right ventricular pacing lead will be implanted in the apex region of the right ventricle |
| Right Ventricular Septum (RVS) | Experimental | Procedure: Permanent Cardiac Pacemaker ImplantationIn the RVS group the right ventricular pacing lead will be implanted in the septal region (mid septum) of the right ventricle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for a dual chambers cardiac pacemaker device (DDD/DR) according to current guidelines
- Patients who are able to understand and sign an informed written consent
- Patients who will conduct the follow-up in the center for at least 24 months
- Patients age ≥ 18
Key exclusion criteria (5 listed)
- Patients with chronic atrial fibrillation or atrial arrhythmias not controlled within 90 days before enrollment
- Pre-existing permanent cardiac pacemaker (PM), defibrillator (ICD) or cardiac resynchronization therapy device (CRT)
- Unplanned or emergency access to the hospital and / or inability to measure the dyssynchrony for the absence of spontaneous rhythm
- Patients participating in other studies that clearly impact the clinical practice of the center or whose protocol would conflict or affect the outcome of this study
- Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
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 |
|---|---|---|
| Permanent Cardiac Pacemaker Implantation | Procedure or surgery | Right Ventricular Apex (RVA), Right Ventricular Septum (RVS) |
Primary outcome
LV dyssynchrony as measured by Electromechanical delay (EMD
Time frame: 2 weeks
The primary outcome measure of this study is to compare the effect of RV Septal (RVS) versus RV Apical (RVA) pacing as measured by echocardiographic/Doppler Index
6 secondary outcomes
Number of heart failure-related hospitalization
Time frame: 24 months
Right ventricular lead and total implant procedure time, fluoroscopy time
Time frame: Implant
Change from baseline in R wave in 12-lead ECG
Time frame: 24 months
Absolute change in LVEF
Time frame: 24 months
LV dyssynchrony as measured by Electromechanical delay (EMD)
Time frame: 24 months
Symptoms and quality of life scores
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Derived from this study: PubMed 29951525Muto C, Calvi V, Botto GL, Pecora D, Porcelli D, Costa A, Ciaramitaro G, Airo Farulla R, Rago A, Calvanese R, Baratto MT, Reggiani A, Giammaria M, Patane S, Campari M, Valsecchi S, Maglia G. Chronic Apical and Nonapical Right Ventricular Pacing in Patients with High-Grade Atrioventricular Block: Results of the Right Pace Study. Biomed Res Int. 2018 May 22;2018:1404659. doi: 10.1155/2018/1404659. eCollection 2018.
- Derived from this study: PubMed 25465496Muto C, Calvi V, Botto GL, Pecora D, Ciaramitaro G, Valsecchi S, Malacrida M, Maglia G. Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial. Contemp Clin Trials. 2014 Nov;39(2):320-6. doi: 10.1016/j.cct.2014.10.006. Epub 2014 Oct 22.
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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.
Carmine Muto, MD study chair
Ospedale Santa Maria di Loreto Mare
Valeria Calvi, MD study chair
Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permanent Cardiac Pacemaker Implantation in people with Bradycardia and Heart Block, run by Ospedale Santa Maria di Loreto Mare at 2 sites in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV dyssynchrony as measured by Electromechanical delay (EMD (time frame: 2 weeks). 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 NCT01647490, which also lists 2 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 23 Jul 2012.