Trial Outcomes & Findings for QP ExCELs: MultiPole Pacing (MPP) Sub-Study (NCT NCT03155724)

Results Overview

Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) : * "Improved" * No HF hospitalization or cardiovascular death, AND * NYHA class is improved * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

Enrollment to 6 Months

Results posted on

2021-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	MultiPole Pacing Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Overall Study STARTED	53
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	MultiPole Pacing Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Overall Study Death	3
Overall Study Physician Decision	1
Overall Study Study closure	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MultiPole Pacing n=53 Participants Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Age, Continuous	69.3 Years STANDARD_DEVIATION 12.13 • n=53 Participants
Sex: Female, Male Female	11 Participants n=53 Participants
Sex: Female, Male Male	42 Participants n=53 Participants
Height	68.5 in STANDARD_DEVIATION 4.0 • n=53 Participants
Weight	212.7 Pounds STANDARD_DEVIATION 52.69 • n=53 Participants

PRIMARY outcome

Timeframe: Enrollment to 6 Months

Population: Participants who have completed the MultiPole Pacing (MPP) Sub-study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020.

Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) : * "Improved" * No HF hospitalization or cardiovascular death, AND * NYHA class is improved * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened

Outcome measures

Outcome measures
Measure	MultiPole Pacing n=45 Participants Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature Improved	16 Participants
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature Unchanged	23 Participants
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature Worsened	6 Participants

SECONDARY outcome

Timeframe: Enrollment to 6 Months

Population: Evaluable participants for Secondary Endpoint 1 include all participants who have been enrolled into the MPP Sub-Study.

Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR).

Outcome measures

Outcome measures
Measure	MultiPole Pacing n=53 Participants Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.	100 percentage of participants Interval 93.28 to 100.0

SECONDARY outcome

Timeframe: Enrollment to 6 Months

Population: Participants who have completed the MPP Sub-Study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020.

Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse). Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit): * "Improved" * No HF hospitalization or cardiovascular death, AND * Neither NYHA class is worsened or PGA is worsened ("worse" or "markedly worse"), AND * NYHA class is improved or PGA is improved ("better" or "markedly better") * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged, AND * PGA is unchanged ("unchanged") * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened or PGA is worsened ("worse" or "markedly worse")

Outcome measures

Outcome measures
Measure	MultiPole Pacing n=45 Participants Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA Improved	27 Participants
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA Unchanged	11 Participants
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA Worsened	7 Participants

SECONDARY outcome

Timeframe: Enrollment to 6 Months

Population: Participants who have completed the MPP Sub-Study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020.

Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) : * "Improved" * No HF hospitalization or cardiovascular death, AND * NYHA class is improved * "Unchanged" * No HF hospitalization or cardiovascular death, AND * NYHA class is unchanged * "Worsened" * HF hospitalization or cardiovascular death has occurred, OR * NYHA class is worsened

Outcome measures

Outcome measures
Measure	MultiPole Pacing n=45 Participants Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
CCS Responder Status Utilizing an Expanded Responder Classification Responder	39 Participants
CCS Responder Status Utilizing an Expanded Responder Classification Non-Responder	6 Participants

Adverse Events

MultiPole Pacing

Serious events: 5 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	MultiPole Pacing n=53 participants at risk Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Cardiac disorders Heart Failure Hospitalization	5.7% 3/53 • 6 months Sites were required to report any cardiovascular hospitalizations and any other hospitalizations in which cardiovascular symptoms occur on or before the date of the MPP 6-Month follow-up. These hospitalizations were categorized as Heart Failure Hospitalization, Non-Heart Failure Hospitalization, or if applicable, Non-system related/non-protocol defined. Extracardiac stimulation was assessed/categorized however other specific adverse event terms were not assessed.
General disorders Non-Heart failure Hospitalization	5.7% 3/53 • 6 months Sites were required to report any cardiovascular hospitalizations and any other hospitalizations in which cardiovascular symptoms occur on or before the date of the MPP 6-Month follow-up. These hospitalizations were categorized as Heart Failure Hospitalization, Non-Heart Failure Hospitalization, or if applicable, Non-system related/non-protocol defined. Extracardiac stimulation was assessed/categorized however other specific adverse event terms were not assessed.

Other adverse events

Other adverse events
Measure	MultiPole Pacing n=53 participants at risk Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON.
Cardiac disorders Non-system related/ Non Protocol-defined	3.8% 2/53 • Number of events 2 • 6 months Sites were required to report any cardiovascular hospitalizations and any other hospitalizations in which cardiovascular symptoms occur on or before the date of the MPP 6-Month follow-up. These hospitalizations were categorized as Heart Failure Hospitalization, Non-Heart Failure Hospitalization, or if applicable, Non-system related/non-protocol defined. Extracardiac stimulation was assessed/categorized however other specific adverse event terms were not assessed.
Cardiac disorders Extracardiac stimulation	7.5% 4/53 • Number of events 4 • 6 months Sites were required to report any cardiovascular hospitalizations and any other hospitalizations in which cardiovascular symptoms occur on or before the date of the MPP 6-Month follow-up. These hospitalizations were categorized as Heart Failure Hospitalization, Non-Heart Failure Hospitalization, or if applicable, Non-system related/non-protocol defined. Extracardiac stimulation was assessed/categorized however other specific adverse event terms were not assessed.

Additional Information

Clinical Studies Engineer Manager

BIOTRONIK

Phone: 800-547-0394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place