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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Block; Bradycardia; Sick Sinus Syndrome
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95124
    • Recruiting
    • Azienda Ospedaliero Universitaria "Vittorio Emanuele"
    • Principal Investigator: Valeria Calvi, MD
  • Naples, Italy, 80142
    • Recruiting
    • Ospedale Santa Maria di Loreto Mare
    • Contact: Carmine Muto, MD; Email: carminemuto@libero.it
    • Principal Investigator: Carmine Muto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of heart failure-related hospitalization	To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing	24 months
Right ventricular lead and total implant procedure time, fluoroscopy time	To compare the procedural time of RVS versus RVA pacing	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	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	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	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	24 months

Collaborators and Investigators

• Sponsor: Ospedale Santa Maria di Loreto Mare
• Investigators: Study Chair: Valeria Calvi, MD, Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto

Publications and helpful links

General 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.
• Muto 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): July 1, 2013
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (ESTIMATE): July 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Bradycardia; Sick Sinus Syndrome
• Other Study ID Numbers: LM-003