NCT00246805

Brief Summary

The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 28, 2011

Completed
Last Updated

September 28, 2011

Status Verified

March 1, 2010

Enrollment Period

3 years

First QC Date

October 28, 2005

Results QC Date

November 6, 2009

Last Update Submit

August 23, 2011

Conditions

Permanent Atrial Fibrillation

Keywords

Permanent atrial fibrillationVVI(R) pacingrate regularization

Outcome Measures

Primary Outcomes (1)

  • Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)

    Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.

    June 2009

Secondary Outcomes (4)

  • Evaluation of Rate Irregularity Indicators and Patient's Symptoms

    January 2009

  • Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation

    January 2009

  • Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate

    January 2009

  • Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization

    January 2009

Study Arms (2)

1. VRS ON

EXPERIMENTAL

Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS) ON or OFF. This arm (1) is randomized to Function Ventricular Rate Stabilization ON.

Device: Vitatron pacemaker C20 SSIR or T20 SSIR models

2. VRS OFF

NO INTERVENTION

Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS)ON or OFF. This arm (2) is randomized to Function Ventricular Rate Stabilization OFF.

Interventions

Vitatron pacemaker C20 SSIR or T20 SSIR modelsDEVICE

VRS: special function that automatically adapts pacing rate to regularize cardiac cycles

1. VRS ON

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has signed informed consent form
  • Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month
  • New York Heart Association (NYHA) Class I, II, III
  • Patient is able to comply with follow-up times and will comply with the protocol
  • \> 18 years of age

You may not qualify if:

  • Paroxysmal atrial fibrillation
  • NYHA Class IV
  • Left ventricular ejection fraction (LVEF) \< 35
  • Patients with unstable angina
  • Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment
  • Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)
  • Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability
  • Life expectancy \< 12 months due to other medical conditions
  • Pregnancy
  • The patient is enrolled in any concurrent (drug and/or device) study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Divisione di Cardiologia - Ospedale Civile

Livorno, LI, 57100, Italy

Location

Divisione di Cardiologia - ospedale Civile

Rieti, RI, 02100, Italy

Location

Divisione di Cardiologia - Ospedale Civile

Acqui Terme, 15011, Italy

Location

Divisione di Cardiologia - Az. Ospedaliera Umberto I

Ancona, 60020, Italy

Location

Divisione di Cardiologia - USL 8

Arezzo, 52100, Italy

Location

Divisione di Cardiologia- Ospedale di Cecina

Cecina, 57023, Italy

Location

Divisione di Cardiologia - Azienda USL 12 di Viareggio

Lido di Camaiore, 55043, Italy

Location

Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita

Novara, 28100, Italy

Location

Divisione di Cardiologia - ASL 22

Novi Ligure, 15067, Italy

Location

Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana

Pisa, 56127, Italy

Location

Divisione di Cardiologia - Azienda USL 4

Prato, 59100, Italy

Location

Divisione di Cardiologia - Ospedale Maria Vittoria

Torino, 10100, Italy

Location

Ospedalr di Verbania

Verbania, Italy

Location

Related Publications (4)

  • Proclemer A et al, Registro Italiano Pacemaker e Defibrillatori. Bollettino Periodico 2001. G Ital Aritmol Cardiostim 2002;5:5-31.

    BACKGROUND

  • Wittkampf FH, de Jongste MJ, Lie HI, Meijler FL. Effect of right ventricular pacing on ventricular rhythm during atrial fibrillation. J Am Coll Cardiol. 1988 Mar;11(3):539-45. doi: 10.1016/0735-1097(88)91528-8.

    PMID: 2449483BACKGROUND

  • Lau CP, Jiang ZY, Tang MO. Efficacy of ventricular rate stabilization by right ventricular pacing during atrial fibrillation. Pacing Clin Electrophysiol. 1998 Mar;21(3):542-8. doi: 10.1111/j.1540-8159.1998.tb00096.x.

    PMID: 9558685BACKGROUND

  • Mazzocca G, Giovannini T, Frascarelli F, Fabiani A, Burali A, Giappichini G, Bidi G, Bernabo D, Manfredini E, Corbucci G. Heart rate regularisation in patients with permanent atrial fibrillation implanted with a VVI(R) pacemaker. Europace. 2004 May;6(3):236-42. doi: 10.1016/j.eupc.2004.02.002.

    PMID: 15121077BACKGROUND

Results Point of Contact

Title
Giorgio Corbucci - Sr Principal Scientist
Organization
Medtronic BRC - Medtronic Italia
giovanna.zucchi@medtronic.com
+39 02 241371

Study Officials

  • Giorgio Corbucci, PhD

    Vitatron Medical Italia

    STUDY DIRECTOR

  • Eraldo Occhetta, MD

    Ospedale Maggiore della Misericordia - Novara

    PRINCIPAL INVESTIGATOR

  • Gianfranco Mazzocca, MD

    Ospedale di Cecina (LI)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 28, 2011

Results First Posted

September 28, 2011

Record last verified: 2010-03

Locations

IT(13)