search
Back to results

Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

Primary Purpose

Sick Sinus Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Vitatron T70 DR
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring Cardiac Pacing, artificial, Atrial Fibrillation, Heart Failure, Pacemaker leads, Pacing Mode

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Symptomatic sinus bradycardia, Sinusarrest Symptomatic SA block Bradycardia-Tachycardia-Syndrome Binodal diseases Exclusion Criteria: 1st degree AV Block 2nd degree AV block 3rd degree AV block Total right bundle branch block Indication for biventricular stimulation Inter atrial conduction delays (P-wave > 150MS) Permanent or therapy refractory Atrial Fibrillation Heart Failure acc. NYHA III or IV Myocardial Infarction less than 6 months before pacemaker implant Hypertrophic obstructive cardiomyopathy Symptomatic hypo- or hyperthyreosis Cardiogenic shock Pregnancy Lactation period Unstable angina pectoris Poorly controlled Diabetes mellitus Neuromuscular diseases Patients under 18 years of age Patients involved in other studies Reduced expectancy of life due to other diseases Patients who cannot attend follow-up visits regularly

Sites / Locations

  • Klinikum CoburgRecruiting
  • Universitätskrankenhaus EppendorfRecruiting
  • Kardiologische GemeinschaftspraxisRecruiting
  • Kardiologische PraxisRecruiting
  • Sophien- und Hufelandklinikum GmbHRecruiting

Outcomes

Primary Outcome Measures

Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor

Secondary Outcome Measures

Number of patients with atrial fibrillation or heart failure > NYHA II
AF burden
Symptomatic atrial fibrillation
Time period to first recurrence of AF
Number of patients without recurrence of AF
Mean duration of sinus rhythm
Course of Wenckebach point
Second- and third-degree AV block
Reprogramming from AAI to DDD
Fraction of atrial versus ventricular pacing
Safety of treatment, complications
Number of cardioversions
Patients with persistent atrial fibrillation (AF >48h)
Patients with permanent atrial fibrillation (AF throughout the follow-up period)
Hospital admissions for cardiac reasons

Full Information

First Posted
September 9, 2005
Last Updated
August 1, 2011
Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT00161551
Brief Title
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
Official Title
A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).
Detailed Description
Background: Dual-chamber pacemaker therapy has become the mainstay for treating symptomatic sick sinus syndrome (SSS). This approach aims to results in a physiologic conduction pattern, while protecting against atrioventricular conduction anomalies. Smaller studies and subgroup analyses of larger trials suggest that ventricular stimulation associated with this treatment has adverse effects, especially an increased incidence of atrial fibrillation and heart failure. Methods: In MODEST, a study on patients with sick sinus syndrome who have an indication for pacing therapy, atrial pacing (AAI) is compared with dual-chamber pacing (DDD) combined with a novel algorithm developed to lower the number of ventricularly paced beats. The study aims to assess the impact of ventricular pacing on the development of atrial arrhythmias and to test the hypothesis that DDD pacing using the algorithm is associated with a higher rate of atrial arrhythmias as atrial pacing. Included will be patients with SSS and no high degree AV node disease except for patients with first-degree AV block ≤300ms. Patients will be followed stratified by their Wenckebach point (≥ 120 bpm versus < 120 bpm). Conclusion: MODEST is a large, prospective, randomized, multicenter trial aiming to compare a novel type of dual-chamber pacing approach (that includes an algorithm designed to lower the number of ventricularly paced beats) with pure atrial pacing, assessing the impact on the incidence of atrial arrhythmias in patients with sick sinus syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome
Keywords
Cardiac Pacing, artificial, Atrial Fibrillation, Heart Failure, Pacemaker leads, Pacing Mode

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vitatron T70 DR
Primary Outcome Measure Information:
Title
Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor
Secondary Outcome Measure Information:
Title
Number of patients with atrial fibrillation or heart failure > NYHA II
Title
AF burden
Title
Symptomatic atrial fibrillation
Title
Time period to first recurrence of AF
Title
Number of patients without recurrence of AF
Title
Mean duration of sinus rhythm
Title
Course of Wenckebach point
Title
Second- and third-degree AV block
Title
Reprogramming from AAI to DDD
Title
Fraction of atrial versus ventricular pacing
Title
Safety of treatment, complications
Title
Number of cardioversions
Title
Patients with persistent atrial fibrillation (AF >48h)
Title
Patients with permanent atrial fibrillation (AF throughout the follow-up period)
Title
Hospital admissions for cardiac reasons

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic sinus bradycardia, Sinusarrest Symptomatic SA block Bradycardia-Tachycardia-Syndrome Binodal diseases Exclusion Criteria: 1st degree AV Block 2nd degree AV block 3rd degree AV block Total right bundle branch block Indication for biventricular stimulation Inter atrial conduction delays (P-wave > 150MS) Permanent or therapy refractory Atrial Fibrillation Heart Failure acc. NYHA III or IV Myocardial Infarction less than 6 months before pacemaker implant Hypertrophic obstructive cardiomyopathy Symptomatic hypo- or hyperthyreosis Cardiogenic shock Pregnancy Lactation period Unstable angina pectoris Poorly controlled Diabetes mellitus Neuromuscular diseases Patients under 18 years of age Patients involved in other studies Reduced expectancy of life due to other diseases Patients who cannot attend follow-up visits regularly
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Reimers, Dipl. Documentalist
Phone
+49 21152930
Email
Matthias.reimers@vitatron.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steffen Gazarek, Dr., Engineer
Phone
+49 1729135662
Email
steffen.gazarek@vitatron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Schibgilla, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V. Schibgilla, MD
Phone
+49 9561220
Ext
6348
Email
v.schibgilla@t-online.de
First Name & Middle Initial & Last Name & Degree
V. Schibgilla, MD
Facility Name
Universitätskrankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Schuchert, MD
Phone
+49 40428030
Ext
5765
Email
schuchert@uke.uni-hamburg.de
First Name & Middle Initial & Last Name & Degree
A. Schuchert, MD
Facility Name
Kardiologische Gemeinschaftspraxis
City
Papenburg
ZIP/Postal Code
26871
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Wilke, MD
Phone
+49 4961992013
Email
Praxis@Kardiologie-Papenburg.de
First Name & Middle Initial & Last Name & Degree
A. Wilke, MD
Facility Name
Kardiologische Praxis
City
Starnberg-Percha
ZIP/Postal Code
82319
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Frey, MD
Phone
+49 8151559055
Email
kardiologie-sta@t-online.de
First Name & Middle Initial & Last Name & Degree
A. Frey, MD
Facility Name
Sophien- und Hufelandklinikum GmbH
City
Weimar
ZIP/Postal Code
99425
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. Ebner, PD MD
Phone
+49 3643571100
Email
innere1@klinikum-weimar.de
First Name & Middle Initial & Last Name & Degree
E. Ebner, PD MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
9545357
Citation
Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.
Results Reference
background
PubMed Identifier
12063369
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. doi: 10.1056/NEJMoa013040.
Results Reference
background
PubMed Identifier
9652562
Citation
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. doi: 10.1016/S0140-6736(97)03425-9.
Results Reference
background
PubMed Identifier
12932590
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. doi: 10.1016/s0735-1097(03)00757-5.
Results Reference
background
PubMed Identifier
10805823
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. doi: 10.1056/NEJM200005113421902.
Results Reference
background
PubMed Identifier
9519322
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. doi: 10.1053/euhj.1997.0616.
Results Reference
background
PubMed Identifier
14707022
Citation
Kerr CR, Connolly SJ, Abdollah H, Roberts RS, Gent M, Yusuf S, Gillis AM, Tang AS, Talajic M, Klein GJ, Newman DM. Canadian Trial of Physiological Pacing: Effects of physiological pacing during long-term follow-up. Circulation. 2004 Jan 27;109(3):357-62. doi: 10.1161/01.CIR.0000109490.72104.EE. Epub 2004 Jan 5.
Results Reference
background
PubMed Identifier
12495391
Citation
Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.
Results Reference
background

Learn more about this trial

Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

We'll reach out to this number within 24 hrs