Ventricular Pacing Site Selection (V-PASS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atrioventricular Block	Procedure: Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic BRC:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Heart failure
Rhythm disorders

Estimated Enrollment:	100
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292383

Contacts

Contact: Matthias E Reimers, Dipl. Documentalist	0049021152930 ext 422	Matthias.reimers@vitatron.com
Contact: Steffen Gazarek, Dr., Engineer	004901729135662	steffen.gazarek@vitatron.com

Locations

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

Sponsors and Collaborators

Medtronic BRC

Vitatron GmbH

Investigators

Principal Investigator:

Jochem F. Stockinger, MD

Herzzentrum Bad Krozingen

More Information

Publications:

Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL, Gibbons RJ, Antman EM, Alpert JS, Gregoratos G, Hiratzka LF, Faxon DP, Jacobs AK, Fuster V, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines/North American Society for Pacing and Electrophysiology Committee to Update the 1998 Pacemaker Guidelines. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation. 2002 Oct 15;106(16):2145-61. No abstract available.

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. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62.

Frohlig G, Schwaab B, Kindermann M. Selective site pacing: the right ventricular approach. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):855-61. Review.

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.

ClinicalTrials.gov Identifier:	NCT00292383 History of Changes
Other Study ID Numbers:	V-PASS V.1.2.
Study First Received:	February 14, 2006
Last Updated:	August 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic BRC:

Cardiac Pacing, artificial
Atrial Fibrillation
Heart failure

Pacemaker leads
Lead position
Higher degree AV-Block

Additional relevant MeSH terms:

Atrial Fibrillation
Atrioventricular Block
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Block

ClinicalTrials.gov processed this record on May 22, 2013