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

NCT01647490 | Unknown

• 1 other identifier: LM-003
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 2

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.

Conditions

Bradycardia; Heart Block; Sick Sinus Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of heart failure-related hospitalization

  24 months

• Right ventricular lead and total implant procedure time, fluoroscopy time

  Implant

• Change from baseline in R wave in 12-lead ECG

  24 months

• Absolute change in LVEF

  24 months

• LV dyssynchrony as measured by Electromechanical delay (EMD)

  24 months

Study Arms (2)

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

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

Procedure: Permanent Cardiac Pacemaker Implantation

Interventions

Permanent Cardiac Pacemaker Implantation PROCEDURE

Right Ventricular Apex (RVA); Right Ventricular Septum (RVS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Santa Maria di Loreto Mare: lead

Study Sites (2)

Azienda Ospedaliero Universitaria "Vittorio Emanuele"

Catania, 95124, Italy

RECRUITING

Ospedale Santa Maria di Loreto Mare

Naples, 80142, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 29951525 DERIVED

• 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.

  PMID: 25465496 DERIVED

MeSH Terms

Conditions

Bradycardia; Heart Block; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Arrhythmia, Sinus

Study Officials

• Carmine Muto, MD

  Ospedale Santa Maria di Loreto Mare

  STUDY CHAIR

• Valeria Calvi, MD

  Azienda Ospedaliero Universitaria "Vittorio Emanuele" - Ferrarotto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Electrophysiology and Pacing Unit Director

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2015
• Last Updated: July 23, 2012

Record last verified: 2012-07

Locations

IT (2)