Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads (EffaceQ)
This study is currently recruiting participants.
Verified November 2011 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01484613
First received: November 30, 2011
Last updated: December 1, 2011
Last verified: November 2011
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Purpose
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 | Intervention |
|---|---|
|
Heart Failure |
Device: quadripolar LV lead (Quartet) |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Percentage of patients with at least one acceptable lead vector [ Time Frame: Pre hospital discharge (PHD) to 3 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]Minnesota living with heart failure questionaire
- Phrenic nerve stimulation (PNS) [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
- Incidence of PNS per LV pacing vector
- Freedom from PNS for the permanently programmed LV vector
- LV pacing thresholds [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
- Finally programmed LV lead vector [ Time Frame: PHD to 3 months ] [ Designated as safety issue: No ]
- Need for reprogramming
- Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors
| Estimated Enrollment: | 337 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Quadripolar lead
All participants receive a CRTD 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 Name: 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 2.5V@0.5ms
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who are planned for being implanted with a CRT-D system in the participating centers.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484613
Contacts
| Contact: Johannes Brachmann, Prof. | +49 9561-22-6348 | johannes.brachmann@klinikum-coburg.de |
Locations
| Germany | |
| Klinikum Coburg GmbH | Not yet recruiting |
| Coburg, Germany, 96450 | |
| Contact: Johannes Brachmann, Prof. | |
| Principal Investigator: Johannes Brachmann, Prof. | |
| Cardioangiologisches Centrum Bethanien | Recruiting |
| Frankfurt am Main, Germany, 60389 | |
| Contact: Oliver Przibille, Dr. | |
| Principal Investigator: Oliver Przibille, Dr. | |
| Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem | Not yet recruiting |
| Göttingen, Germany, 37073 | |
| Contact: Claudius Hansen, Dr. | |
| Principal Investigator: Claudius Hansen, Dr. | |
| Marien-Hospital | Recruiting |
| Marl, Germany, 45768 | |
| Contact: Michael Markant, Dr. | |
| Principal Investigator: Michael Markant, Dr. | |
| Niels-Stensen-Kliniken Marienhospital Osnabrück | Not yet recruiting |
| Osnabrück, Germany, 49074 | |
| Contact: Heinrich Weglage, Dr. | |
| Principal Investigator: Heinrich Weglage, Dr. | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Johannes Brachmann, Prof. | Klinikum Coburg GmbH |
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01484613 History of Changes |
| Other Study ID Numbers: | H56 |
| Study First Received: | November 30, 2011 |
| Last Updated: | December 1, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by St. Jude Medical:
|
Hear Failure Cardiac resynchronization CRTD quadripolar |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013