PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

Cardiovascular Diseases Clinical Trial

Official title:

PreFER MVP for Elective Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293241
• Other study ID #: Version 2-Aug 21, 2007
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2006
• Last updated: June 26, 2015
• Start date: February 2006
• Est. completion date: August 2011

Study information

• Verified date: June 2015
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.

Description:

A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.

Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.

MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.

The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [VDD]) for a minimum time duration of 2 years

• Planned to be replaced or replaced with a device including the MVP feature

• Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.

• Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion

• Have signed the informed consent

• Have no need to change the pacing mode or the atrioventricular (AV) intervals.

Exclusion Criteria:

• Patients with a cardiac resynchronization therapy (CRT) indication

• Permanent AF

• Permanent AV block

• Inability to complete follow-up visits at a study center.

• Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent

• Planned cardiovascular intervention

• Inclusion in another clinical trial that will affect the objectives of this study

• Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Managed Ventricular Pacing programmed ON/OFF
Device programming

Locations

Country	Name	City	State
Netherlands	Medtronic Bakken Research Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant	Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.; Hospitalization is defined as: admission to hospital involving one overnight stay or; emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition; Cardiovascular is defined as new or worsening: heart failure (HF),; angina,; myocardial infarction (MI),; any arrhythmia,; stroke,; transient ischemic attack (TIA),; acute peripheral vascular emergencies,; pulmonary embolism.	Implant to 2 years post-implant	No
Secondary	Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.	Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant	Implant to 2 years post-implant	No
Secondary	Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant	Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria: 7 days in a row with device diagnostic showing 20 or more hours in AT/AF or; a cardioversion was done to terminate AT/AF or; the patient is during 2 consecutive follow-up (FU) visits in AT/AF	Implant to 2 years post-implant	No
Secondary	Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant	Time to development of permanent AF fulfilling one of the following criteria: 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or; 7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient	Implant to 2 years post-implant	No
Secondary	Ventricular Pacing Percentage	Endpoint: Cumulative percentage ventricular pacing documented in the device memory	Implant to 2 years post-implant	No
Secondary	Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time	Endpoint: LVEF (%) difference between 2 year post implant and baseline	Implant to 2 years post-implant	No
Secondary	Change in New York Heart Association (NYHA) Functional Class	Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.; II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.; III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.; IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.	Baseline, one year and 2 year post-implant	No
Secondary	Change in Use of Anticoagulation	Endpoint: Use of Anticoagulation at enrollment and every follow-up visit	Implant to 2 years post-implant	No
Secondary	Change in the Use of Cardiovascular Medication Over Time	Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant	Implant to 2 years post-implant	No
Secondary	Incidence of High Voltage Therapies	Endpoint: A high voltage therapy delivered	Implant to 2 years post-implant	No
Secondary	Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant	Time to patient death from any cause	Implant to 2 years post-implant	No
Secondary	Stroke	Endpoint: Stroke	Implant to 2 years post-implant	No
Secondary	Number of Cardiovascular Related Hospitalizations	Endpoint: Number of Cardiovascular hospitalizations per subject	Implant to 4 years post-implant	No
Secondary	Duration of Cardiovascular Related Hospitalizations	Endpoint: Duration of Cardiovascular Hospitalizations per subject	Implant to 4 years post-implant	No
Secondary	Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients	Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication	Implant to 2 years post-implant	No
Secondary	Change in PR Interval, Change in QRS Duration and Change in P-wave Duration	Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU	Implant to 2 years post-implant	No
Secondary	Patient Symptoms	Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup	Implant to 2 years post-implant	No
Secondary	Atrial Pacing Percentage	Endpoint: Cumulative percentage atrial pacing documented in the device memory	2 years post-implant	No
Secondary	Health State	Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.	2 years post-implant	No