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This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.
This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.
Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiPoint Pacing "On" | Experimental | Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period. |
|
| MultiPoint Pacing "Off" | Active Comparator | Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy with MultiPoint Pacing | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP) | Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient. | Baseline. 3-Month. 6-Month. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neurohormonal Activation | Renin, Aldosteron, Norepinephrine, Endothelin-1. | Baseline. 3-Month. 6-Month. |
| Heart Failure Hospitalizations | 3-Month. 6-Month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni B Forleo, MD, PhD | University of Rome Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico St. Ambrogio | Milan | 20149 | Italy | |||
| Policlinico Tor Vergata |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24291411 | Background | Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Saviano M, Baldi M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm. 2014 Mar;11(3):394-401. doi: 10.1016/j.hrthm.2013.11.023. Epub 2013 Nov 28. | |
| 24626999 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| New York Heart Association (NYHA) Class changes | Baseline. 3-Month. 6-Month. |
| Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire | Baseline. 3-Month. 6-Month. |
| Echocardiographic changes | Left ventricular end diastolic volume. Left ventricular end systolic volume. Left ventricular ejection fraction. Mitral regurgitation severity. | Baseline. 3-Month. 6-Month. |
| Appropriate device interventions (anti-tachycardia pacing or shock) | 3-Month. 6-Month. |
| Phrenic Nerve Complication Free Rate | 3-Month. 6-Month. |
| Occurrence of atrial and ventricular arrhythmias (amount and duration [h/day]). | 3-Month. 6-Month. |
| Flow-mediated vasodilation | Differences in FMD between groups | Baseline. 3-month. 6-month |
| Packer's clinical composite score | Distribution of "improved", "unchanged" and "worsened" patients as defined per Packer's clinical composite score | Baseline. 3-month. 6-month. |
| 6-Minute-Walking-Distance | The distance walked by subjects during a 6 minutes walking test | Baseline. 3 Month. 6 Month. |
| Rome |
| Italy |
| Background |
| Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14. |