MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

Atrial Fibrillation Clinical Trial

Official title:

MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262119
• Other study ID #: MNV-20-171005
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2005
• Last updated: May 9, 2014
• Start date: February 2006
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.

Description:

Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development compared to DDDR pacing in sinus node disfunction patients.

Several authors have shown that, in patients with intact AV conduction, unnecessary chronic RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and congestive heart failure. These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects.

The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV conduction.

Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent AF, cardiovascular hospitalizations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Class I/Class II indications for dual chamber pacing

• Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since maximum 2 weeks

• History of atrial arrhythmias (at least one electrocardiogram [ECG] or Holter documented episodes in the last 12 months)

Exclusion Criteria:

• Less than 18 years of age

• Pregnancy

• Unwilling or unable to give informed consent or to commit to follow-up schedule

• Medical conditions that preclude protocol required testing or limit study participation

• Enrolled or intend to participate in another clinical trial during the course of this study

• A life expectancy of less than 2 years

• Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implant

• Anticipated major cardiac surgery within the course of this study

• Permanent III degree AV-block or history of AV node ablation

• History of permanent AF (as defined below)

• AF ablation (left pulmonary veins) or other cardiac surgery < 3 months

• Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted within two weeks)

• Uncontrolled hyperthyroidism

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Pacemaker Medtronic EnRhythm
Pacemaker specific programming

Locations

Country	Name	City	State
Italy	Medtronic Italia S.p.A.	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. — View Citation

Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91. — View Citation

Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Andersen HR. Incidence of atrial fibrillation and thromboembolism in a randomised trial of atrial versus dual chamber pacing in 177 patients with sick sinus syndrome. Heart. 2004 Jun;90(6):661-6. — View Citation

Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. — View Citation

Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6. — View Citation

Nielsen JC, Andersen HR, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Heart failure and echocardiographic changes during long-term follow-up of patients with sick sinus syndrome randomized to single-chamber atrial or ventricular pacing. Circulation. 1998 Mar 17;97(10):987-95. — View Citation

Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years	The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.	2 years	Yes
Secondary	Death for All Causes at 2 Years	Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years	2 years	Yes
Secondary	Incidence of Permanent Atrial Fibrillation at 2 Years	Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years	2 years	No
Secondary	Incidence of Cardiovascular Hospitalizations at 2 Years	Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years	2 years	No
Secondary	Burden of Composite Clinical Endpoint		2 years	Yes
Secondary	Subjects' Symptoms		2 years	No
Secondary	Heart Failure Medications		2 years	No
Secondary	Cumulative Percentage of Ventricular Pacing		2 years	No
Secondary	Cardiovascular Death		2 years	Yes
Secondary	Any Hospitalization		2 years	Yes
Secondary	Atrial Fibrillation Burden		2 years	Yes
Secondary	Persistent Atrial Fibrillation (AF)		2 years	Yes
Secondary	Adverse Events		2 years	Yes
Secondary	Development of Atrioventricular (AV) Block and Pacemaker Dependency		2 years	Yes
Secondary	Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism		2 years	Yes
Secondary	Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation		2 years	No
Secondary	Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay		2 years	No
Secondary	Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients		2 years	No
Secondary	Frequency, Type, and Associated Cost of Health Care Utilization and Utility		2 years	No