EffaceQ: Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01484613

Collaborator

(none)

337

Enrollment

Locations

Duration (Months)

21.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.

Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: quadripolar LV lead (Quartet)

Detailed Description

Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:

Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)

Study Design

Study Type:

Observational

Actual Enrollment :

337 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Quadripolar lead All participants receive a CRT-D system with quadripolar lead	Device: quadripolar LV lead (Quartet) All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from Other Names: Quartet

Arm

Intervention/Treatment

Quadripolar lead

All participants receive a CRT-D system with quadripolar lead

Device: quadripolar LV lead (Quartet)

All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from

Other Names:

Quartet

Outcome Measures

Primary Outcome Measures

Percentage of patients with at least one acceptable lead vector [Pre hospital discharge (PHD) to 3 months]
Definition of acceptable lead vector: Any LV vector that complies in both tested body positions with both criteria: Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold LV pacing threshold is less or equals 2.5V@0.5ms

Secondary Outcome Measures

Quality of Life [Baseline to 3 months]
Minnesota living with heart failure questionaire
Phrenic nerve stimulation (PNS) [PHD to 3 months]
Incidence of PNS per LV pacing vector Freedom from PNS for the permanently programmed LV vector
LV pacing thresholds [PHD to 3 months]
LV pacing thresholds per LV vector Incidence of elevated (>2.5V/0.5ms) LV pacing thresholds per LV vector
Number of acceptable LV lead vectors per patient [PHD to 3 months]
Finally programmed LV lead vector [PHD to 3 months]
Need for reprogramming Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Indication for implantation of a CRT-D
Age >= 18 years
Written informed consent

Exclusion Criteria:

Already implanted LV or coronary sinus lead
Previous unsuccessful LV lead implant attempt
Patient is eligible for heart transplantation
Comorbidities that results in life expectancy of less than 12 months
Known pregnancy
Inability to provide written patient informed consent
Participation to another study with active treatment arm (i.e. randomized studies etc...)
Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
Patient is not able to understand or answer the quality of life questionaire

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Klinikum Coburg GmbH	Coburg	Germany	96450
2	Krankenhaus Mörsenbroich-Rath GmbH	Düsseldorf	Germany	40472
3	Klinikum Esslingen	Esslingen	Germany	73730
4	Cardioangiologisches Centrum Bethanien	Frankfurt am Main	Germany	60389
5	Universitätsklinik Freiburg	Freiburg	Germany	79106
6	Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem	Göttingen	Germany	37073
7	Medizinische Hochschule Hannover	Hannover	Germany	30625
8	Evangelisches Krankenhaus Kalk	Köln	Germany	51103
9	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen	Germany	67063
10	St.-Marien-Hospital GmbH	Lünen	Germany	44534
11	Klinikum Magdeburg gGmbH	Magdeburg	Germany	39130
12	Marien-Hospital	Marl	Germany	45768
13	Klinikum Großhadern der Ludwig-Maximilians-Universität München	München	Germany	81377
14	Universitätsklinikum Münster	Münster	Germany	48149
15	Niels-Stensen-Kliniken Marienhospital Osnabrück	Osnabrück	Germany	49074
16	Klinikum Dorothea Christiane Erxleben GmbH	Quedlinburg	Germany	06484