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

NCT ID: NCT01647490

Last Updated: 2012-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

Brief 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 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.

Conditions

Bradycardia; Heart Block; Sick Sinus Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Right Ventricular Apex (RVA)

In the RVA group the right ventricular pacing lead will be implanted in the apex region of the right ventricle

Group Type: ACTIVE_COMPARATOR

Permanent Cardiac Pacemaker Implantation

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Permanent Cardiac Pacemaker Implantation

Intervention Type: PROCEDURE

Interventions

Permanent Cardiac Pacemaker Implantation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Santa Maria di Loreto Mare

OTHER

Sponsor Role: lead

Responsible Party

Carmine Muto

Electrophysiology and Pacing Unit Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmine Muto, MD

Role: STUDY_CHAIR

Ospedale Santa Maria di Loreto Mare

Valeria Calvi, MD

Role: STUDY_CHAIR

Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto

Locations

Azienda Ospedaliero Universitaria "Vittorio Emanuele"

Catania, , Italy

Site Status: RECRUITING

Ospedale Santa Maria di Loreto Mare

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Valeria Calvi, MD

Role: primary

Carmine Muto, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 29951525 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25465496 (View on PubMed)

Other Identifiers

LM-003

Identifier Type: -

Identifier Source: org_study_id