Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Ospedale Santa Maria di Loreto Mare
Sponsor:
Information provided by (Responsible Party):
Carmine Muto, Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier:
NCT01647490
First received: July 19, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Bradycardia
Heart Block
Sick Sinus Syndrome
Procedure: Permanent Cardiac Pacemaker Implantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of Apical and Alternative Position - Right Pace Study

Resource links provided by NLM:


Further study details as provided by Ospedale Santa Maria di Loreto Mare:

Primary Outcome Measures:
  • LV dyssynchrony as measured by Electromechanical delay (EMD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of heart failure-related hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing

  • Right ventricular lead and total implant procedure time, fluoroscopy time [ Time Frame: Implant ] [ Designated as safety issue: No ]
    To compare the procedural time of RVS versus RVA pacing

  • Change from baseline in R wave in 12-lead ECG [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

  • Absolute change in LVEF [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To evaluate the Left ventricular diastolic and systolic function as measured by Echocardiographic response of absolute change in LVEF

  • LV dyssynchrony as measured by Electromechanical delay (EMD) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

  • Symptoms and quality of life scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 408
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Right Ventricular Apex (RVA)
In the RVA group the right ventricular pacing lead will be implanted in the apex region of the right ventricle
Procedure: Permanent Cardiac Pacemaker Implantation
Experimental: Right Ventricular Septum (RVS)
In the RVS group the right ventricular pacing lead will be implanted in the septal region (mid septum) of the right ventricle
Procedure: Permanent Cardiac Pacemaker Implantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647490

Locations
Italy
Azienda Ospedaliero Universitaria "Vittorio Emanuele" Recruiting
Catania, Italy, 95124
Contact: Valeria Calvi, MD       valcalvi@unict.it   
Principal Investigator: Valeria Calvi, MD         
Ospedale Santa Maria di Loreto Mare Recruiting
Naples, Italy, 80142
Contact: Carmine Muto, MD       carminemuto@libero.it   
Principal Investigator: Carmine Muto, MD         
Sponsors and Collaborators
Ospedale Santa Maria di Loreto Mare
Investigators
Study Chair: Carmine Muto, MD Ospedale Santa Maria di Loreto Mare
Study Chair: Valeria Calvi, MD Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto
  More Information

No publications provided

Responsible Party: Carmine Muto, Electrophysiology and Pacing Unit Director, Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier: NCT01647490     History of Changes
Other Study ID Numbers: LM-003
Study First Received: July 19, 2012
Last Updated: July 19, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Heart Block
Sick Sinus Syndrome
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus

ClinicalTrials.gov processed this record on September 15, 2014