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

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01647490
• Other study ID #: LM-003
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: July 19, 2012
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2012
• Source: Ospedale Santa Maria di Loreto Mare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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 acute and chronic.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: July 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bradycardia
• Heart Block
• Sick Sinus Syndrome

Intervention

Procedure:
• Permanent Cardiac Pacemaker Implantation

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria "Vittorio Emanuele"	Catania
Italy	Ospedale Santa Maria di Loreto Mare	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria di Loreto Mare

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of heart failure-related hospitalization	To compare the rate of heart failure-related hospitalization between RVS versus RVA pacing	24 months	No
Secondary	Right ventricular lead and total implant procedure time, fluoroscopy time	To compare the procedural time of RVS versus RVA pacing	Implant	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No