Clinical Trial: Ventricular Pacing Site Selection (V-PASS)
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
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 Pe
Brief 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.
Detailed Summary:
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.
Sponsor: Medtronic BRC
Current Primary Outcome: Amount of patients in which the ventricular lead position could be positioned successfully according randomization
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- 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
Information By: Medtronic BRC
Dates:
Date Received: February 14, 2006
Date Started:
Date Completion: December 2008
Last Updated: August 1, 2011
Last Verified: October 2007
