Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR in Atrioventricular Block - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Atrioventricular Block

Intervention / Treatment

Procedure: Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR

Detailed Description

AV-Block of higher degree is the primary indication for pacing therapy for about 20% of pacemaker patients. Pacing systems with only ventricular stimulation (VVI and VDD) have a fraction of about 40% of all pacemakers in Germany. About 50% of the implanted pacemakers in Germany are dual-chamber pacemakers and one half of them is used for treatment of AV blocks.

Picture 1: Fractions of pacing indications in Germany Picture 2: Fractions of used pacing modes in Germany /1/

A lot of studies proved in the past that the pacing site influenced the development of hemodynamics, heart failure (HF) and atrial fibrillation (AF). Unfortunately, the results are not commonly applicable or statistically assured. Due to this, further examinations are required in order to get explicit statements regarding application of alternative, nonapical ventricular lead positioning.

Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions (either Group A: Positioning at right ventricular apex or Group B:. Positioning at right ventricular high septum) is feasible. Included patients will already by examined and followed according to protocol. After having proved feasibility of randomized positioning, the data of these patients shall be used for evaluation of the V-PASS study.
Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure. Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Bad Krozingen, Germany, D-79189
    - Recruiting
    - Herzzentrum Bad Krozingen, Elektrophysiologie
    - Contact:
      
      Jochem Stockinger, MD
      
      Phone Number: 248 0049 07633402
      
      Email: JFStockinger@gmx.de
    - Principal Investigator:
      
      Jochem Stockinger, MD
    - Sub-Investigator:
      
      Thomas Blum, MD
  - Heidelberg, Germany, D-69120
    - Not yet recruiting
    - Universitätsklinikum Heidelberg, Innere Medizin III
    - Contact:
      
      Alexander Bauer, MD
      
      Phone Number: 8672 ++49 0622563
      
      Email: Alexander.Bauer@med.uni-heidelberg.de
    - Principal Investigator:
      
      Alexander Bauer, MD
  - Wangen, Germany, D-88239
    - Not yet recruiting
    - Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.
    - Contact:
      
      Jörg Maurus, MD
      
      Phone Number: 1311 0049 00752296
    - Principal Investigator:
      
      Jörg Maurus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with an expected ventricular stimulation rate of >60% in planned pacing therapy. This will be the following pacing indications

Symptomatic first-degree AV block, PQ time >250ms
Second-degree Av block with permanent 2:1 conduction
Permanent third-degree AV block
Paroxysmal first-degree to third-degree Av block, with an anticipated rate of ventricular stimulation >60%
Symptomatic bradyarrhythmia absoluta with permanent atrial fibrillation, with an anticipated rate of ventricular stimulation >60%

Exclusion Criteria:

heart failure acc. NYHA III or IV
Intra-atrial conduction delay (P-wave > 150ms)
Myocardial infarction less then 6 months before pacemaker implant
hypertrophic obstructive cardiomyopathy
Cardiogenic shock
pregnancy
Lactation period
Patients under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Amount of patients in which the ventricular lead position could be positioned successfully according randomization

Secondary Outcome Measures

Outcome Measure
Heart failure
Typical values re operation procedure in both groups
operation time, x-ray time
intraoperative measurements (amplitudes, thresholds)
broad QRS-complexes in both groups
safety of therapy, complications
electrical specific values in both groups
energy consumption, lead impedance
Rhythmologic characteristics in both groups
amount of VESs
episodes of ventricular tachycardia
amount of atrial and ventricular stimulation
BNP-levels in both groups
incidence of co-morbidities in both groups
Atrial Fibrillation, AF burden >1%
Heart failure > NYHA II
Hospitalizations in both groups due to
Rhythm disorders

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Collaborators

Vitatron GmbH

Investigators

Principal Investigator: Jochem F. Stockinger, MD, Herzzentrum Bad Krozingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12. doi: 10.1016/s0002-9149(96)00718-7.
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.
Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf
DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk
SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch
Lemke B., Nowak B. Pfeiffer D. Leitlinien zur Herzschritmachertherapie. Deutsche Gesellschaft für Kardiologie 2005. http://www.dgk.org/leitlinien/LLHerzschrittmacher.pdf
Gregoratos G., Abrams J. Epstein AE, et al. ACC/AHA /NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)(2002). http://www.acc.org/clinical/guidelines/pacemaker/pacemaker.pdf
Frohlig G, Schwaab B, Kindermann M. Selective site pacing: the right ventricular approach. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):855-61. doi: 10.1111/j.1540-8159.2004.00547.x.
Koglek W, Kranig W, Kowalski M, Kronski D, Brandl J, Oberbichler A, Suntinger A, Wutte M, Grimm G, Grove R, Ludorff G. [A simple method for AV-delay determination in dual chamber pacemakers]. Herzschrittmacherther Elektrophysiol. 2000 Dec;11(4):244-53. doi: 10.1007/s003990070023. German.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria