Ventricular Pacing Site Selection (V-PASS)

Atrioventricular Block Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00292383
• Other study ID #: V-PASS V.1.2.
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: August 1, 2011
• Est. completion date: December 2008

Study information

• Verified date: October 2007
• Source: Medtronic BRC
• Contact: Matthias E Reimers, Dipl. Documentalist
• Phone: 0049021152930
• Email: Matthias.reimers[@]vitatron.com
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrioventricular Block

Intervention

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

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen, Elektrophysiologie	Bad Krozingen
Germany	Universitätsklinikum Heidelberg, Innere Medizin III	Heidelberg
Germany	Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.	Wangen

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic BRC	Vitatron GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (9)

DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk

Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 May 27;51(21):e1-62. doi: 10.1016/j.jacc.2008.02.032. Erratum in: J Am Coll Cardiol. 2009 Apr 21;53(16):1473. J Am Coll Cardiol. 2009 Jan 6;53(1):147. — View Citation

Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf

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

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. — View Citation

Koglek W, et al. Eine einfache Methode zur Bestimmung des AV Intervalls bei Zweikammerschrittmachern. 2000. Herzschr Elektrophys. 11: 244-253

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. — View Citation

Lemke B., Nowak B. Pfeiffer D. Leitlinien zur Herzschritmachertherapie. Deutsche Gesellschaft für Kardiologie 2005. http://www.dgk.org/leitlinien/LLHerzschrittmacher.pdf

SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of patients in which the ventricular lead position could be positioned successfully according randomization
Secondary	Typical values re operation procedure in both groups
Secondary	operation time, x-ray time
Secondary	intraoperative measurements (amplitudes, thresholds)
Secondary	broad QRS-complexes in both groups
Secondary	safety of therapy, complications
Secondary	electrical specific values in both groups
Secondary	energy consumption, lead impedance
Secondary	Rhythmologic characteristics in both groups
Secondary	amount of VESs
Secondary	episodes of ventricular tachycardia
Secondary	amount of atrial and ventricular stimulation
Secondary	BNP-levels in both groups
Secondary	incidence of co-morbidities in both groups
Secondary	Atrial Fibrillation, AF burden >1%
Secondary	Heart failure > NYHA II
Secondary	Hospitalizations in both groups due to
Secondary	Heart failure
Secondary	Rhythm disorders