Rationale and design of a randomized trial to assess the safety and efficacy of MultiPoint Pacing (MPP) in cardiac
Gery Tomassoni1, James Baker2, Raffaele Corbisiero3
1Baptist Health Lexington, Lexington, KY, USA.
Insights
The MultiPoint Pacing (MPP) trial will assess if a new pacing method improves outcomes for heart failure patients unresponsive to standard cardiac resynchronization therapy (CRT). This study compares MPP to biventricular (Bi-V) pacing to enhance CRT efficacy.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Up to 40% of heart failure (HF) patients do not benefit from standard cardiac resynchronization therapy (CRT).
- The MultiPoint Pacing (MPP) trial is designed to address this gap in CRT efficacy.
- This study evaluates a novel pacing approach using a single quadripolar lead.
Purpose of the Study:
- To evaluate the safety and efficacy of MultiPoint Pacing (MPP) compared to standard biventricular (Bi-V) pacing in CRT patients.
- To determine if MPP improves hemodynamic and clinical responses in both CRT responders and non-responders.
- To assess the primary safety endpoint of freedom from system-related complications at 9 months.
Main Methods:
- A prospective, randomized, double-blind, controlled study enrolling up to 506 patients with standard CRT-D indications at 50 US centers.
- All patients receive a CRT-D system with a Quartet LV lead capable of both MPP and Bi-V pacing.
- Patients with improved echocardiographic parameters on MPP at 3 months are randomized (1:1) to MPP or Bi-V pacing arms for further evaluation up to 9 months.
Main Results:
- The primary efficacy endpoint is the proportion of responders in the MPP arm versus the Bi-V arm between 3 and 9 months post-implant.
- Patient response is assessed using a composite score including NYHA functional class, patient global assessment, HF events, and cardiovascular death.
- The primary safety endpoint is freedom from system-related complications at 9 months.
Conclusions:
- The trial aims to establish whether MPP, delivered via a single quadripolar LV lead, offers superior hemodynamic and clinical benefits over standard Bi-V pacing.
- Findings will inform optimal pacing strategies for improving CRT outcomes in a broader HF patient population.
- This research addresses a critical need for improved CRT effectiveness in non-responding patients.
Background:
Although the majority of Class III congestive heart failure (HF) patients treated with cardiac resynchronization therapy (CRT) show a clinical benefit, up to 40% of patients do not respond to CRT. This paper reports the design of the MultiPoint Pacing (MPP) trial, a prospective, randomized, double-blind, controlled study to evaluate the safety and efficacy of CRT using MPP compared to standard biventricular (Bi-V) pacing.
Methods:
A maximum of 506 patients with a standard CRT-D indication will be enrolled at up to 50 US centers. All patients will be implanted with a CRT-D system (Quartet LV lead Model 1458Q with a Quadra CRT-D, Abbott) that can deliver both MPP and Bi-V pacing. Standard Bi-V pacing will be activated at implant. At 3 months postimplant, patients in whom the echocardiographic parameters during MPP are equal or better than during Bi-V pacing are randomized (1:1) to either an MPP or Bi-V arm.
Results:
The primary safety endpoint is freedom from system-related complications at 9 months. Each patient's response to CRT will be evaluated using a heart-failure clinical composite score, consisting of a change in NYHA functional class, patient global assessment score, HF events, and cardiovascular death. The primary efficacy endpoint is the proportion of responders in the MPP arm compared with the Bi-V arm between 3 and 9 months.
Conclusion:
This trial seeks to evaluate whether MPP via a single quadripolar LV lead improves hemodynamic and clinical responses to CRT, both in clinical responders and nonresponders.
