AzTrials
AzTrials

Atrioventricular BlockPhase 4NCT00292383

Ventricular Pacing Site Selection (V-PASS)

A Phase 4 study testing Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR in people with Atrioventricular Block, run by Medtronic BRC at 3 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrioventricular Block
What is being tested?
Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
Type of treatment
Surgery or procedure
How many people
100 participants
Where
3 sitesGermany
Study dates
Start not givento Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Matthias E Reimers, Dipl. Documentalist contact

0049021152930 ext. 422

Matthias.reimers@vitatron.com

Steffen Gazarek, Dr., Engineer contact

004901729135662

steffen.gazarek@vitatron.com

Germany3 sites, 3 recruiting

  • Herzzentrum Bad Krozingen, Elektrophysiologie

    Bad Krozingen, D-79189

    Jochem Stockinger, MD, 0049 07633402 ext. 248, JFStockinger@gmx.de

    Jochem Stockinger, MD

    Recruiting

  • Universitätsklinikum Heidelberg, Innere Medizin III

    Heidelberg, D-69120

    Alexander Bauer, MD, ++49 0622563 ext. 8672, Alexander.Bauer@med.uni-heidelberg.de

    Alexander Bauer, MD

    Not yet recruiting

  • Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.

    Wangen, D-88239

    Jörg Maurus, MD, 0049 00752296 ext. 1311

    Jörg Maurus, MD

    Not yet recruiting

Other trials in Germany

About this study

Official title: A Randomized, Prospective Multicenter Pilot Study to Determine the Influence of the Ventricular Pacing Site on the Incidence of Atrial Fibrillation and Heart Failure in Patients With Indication for Permanent Pacemaker Stimulation Therapy.

The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation.

Read the 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.

  1. 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.
  2. 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.
Being tested
Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
Keywords
Cardiac Pacing, artificial, Atrial Fibrillation, Heart failure, Pacemaker leads, Lead position, Higher degree AV-Block
Medical subject headings
Atrioventricular Block, Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of patients in which the ventricular lead position could be positioned successfully according randomization

Secondary outcomes (18)

  1. Typical values re operation procedure in both groups

  2. operation time, x-ray time

  3. intraoperative measurements (amplitudes, thresholds)

  4. broad QRS-complexes in both groups

  5. safety of therapy, complications

  6. electrical specific values in both groups

  7. energy consumption, lead impedance

  8. Rhythmologic characteristics in both groups

  9. amount of VESs

  10. episodes of ventricular tachycardia

  11. amount of atrial and ventricular stimulation

  12. BNP-levels in both groups

  13. incidence of co-morbidities in both groups

  14. Atrial Fibrillation, AF burden >1%

  15. Heart failure > NYHA II

  16. Hospitalizations in both groups due to

  17. Heart failure

  18. Rhythm disorders

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2006 (estimated)
  2. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00292383
Sponsor's protocol ID
V-PASS V.1.2.
Status last verified
Oct 2007
First submitted
14 Feb 2006
Last updated
2 Aug 2011
Results posted
No

Publications

  • 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

  • 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.

    PubMed 12063369

  • 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.

    PubMed 15189516

  • 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.

    PubMed 27515355

  • 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.

    PubMed 9193029

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR in people with Atrioventricular Block, run by Medtronic BRC at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthias E Reimers, Dipl. Documentalist (0049021152930 ext. 422, Matthias.reimers@vitatron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of patients in which the ventricular lead position could be positioned successfully according randomization. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00292383, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in