Trial Outcomes & Findings for Interventricular Delay of Lumax HF-T for Heart Failure (NCT NCT00508391)

Last Updated: 2010-01-26

Results Overview

The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified "not worsened" if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

60 days after enrollment

Results posted on

2010-01-26

Participant Flow

Subjects were recruited from each investigator's general patient population at the medical clinic and selected according to the study inclusion/exclusion criteria.

All subjects enrolled in the study were previously implanted with a Lumax HF-T heart failure device. The study utilized an intention-to-treat analysis where subjects were analyzed according to the randomized treatment order, regardless of whether they received the treatment in the order stipulated by the protocol.

Participant milestones

Participant milestones
Measure	Simultaneous 1st, Optimized 2nd Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
First Treatment STARTED	60	62
First Treatment COMPLETED	54	59
First Treatment NOT COMPLETED	6	3
Second Treatment STARTED	54	59
Second Treatment COMPLETED	52	59
Second Treatment NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Simultaneous 1st, Optimized 2nd Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
First Treatment Withdrawal by Subject	6	3
Second Treatment Withdrawal by Subject	2	0

Baseline Characteristics

Interventricular Delay of Lumax HF-T for Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simultaneous 1st, Optimized 2nd n=60 Participants Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd n=62 Participants Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=99 Participants	27 Participants n=107 Participants	48 Participants n=206 Participants
Age, Categorical >=65 years	39 Participants n=99 Participants	35 Participants n=107 Participants	74 Participants n=206 Participants
Age Continuous	68.2 years STANDARD_DEVIATION 14.1 • n=99 Participants	66.1 years STANDARD_DEVIATION 12.0 • n=107 Participants	67.1 years STANDARD_DEVIATION 13.1 • n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	10 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	44 Participants n=99 Participants	52 Participants n=107 Participants	96 Participants n=206 Participants
Region of Enrollment United States	58 participants n=99 Participants	59 participants n=107 Participants	117 participants n=206 Participants
Region of Enrollment Switzerland	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants

PRIMARY outcome

Timeframe: 60 days after enrollment

Population: Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.

Outcome measures

Outcome measures
Measure	Simultaneous 1st, Optimized 2nd n=51 Participants Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd n=55 Participants Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.	Total Subjects n=106 Participants Total subjects enrolled in study.
Percentage of Subjects Classified as "Not Worsened" for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing	65 Percent of Subjects	62 Percent of Subjects	63 Percent of Subjects

PRIMARY outcome

Timeframe: 60 days after enrollment

The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.

Outcome measures

Outcome measures
Measure	Simultaneous 1st, Optimized 2nd n=60 Participants Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd n=62 Participants Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.	Total Subjects n=122 Participants Total subjects enrolled in study.
Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device	100 Percent of Subjects	100 Percent of Subjects	100 Percent of Subjects

Adverse Events

Simultaneous 1st, Optimized 2nd

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Optimized 1st, Simultaneous 2nd

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Total Subjects

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Simultaneous 1st, Optimized 2nd n=60 participants at risk Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd n=62 participants at risk Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.	Total Subjects n=122 participants at risk Total subjects enrolled in study.
Cardiac disorders Atrial arrhythmia requring invasive intervention to resolve	1.7% 1/60 • Number of events 1 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	1.6% 1/62 • Number of events 1 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	1.6% 2/122 • Number of events 2 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.
Cardiac disorders Ventricular arrhythmia requiring invasive intervention to resolve	0.00% 0/60 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	3.2% 2/62 • Number of events 2 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	1.6% 2/122 • Number of events 2 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.
Cardiac disorders Non-heart failure cardiac symptoms requiring invasive intervention to resolve	1.7% 1/60 • Number of events 1 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	1.6% 1/62 • Number of events 1 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	1.6% 2/122 • Number of events 2 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.
Cardiac disorders Other cardiac condition requiring invasive intervention to resolve	1.7% 1/60 • Number of events 1 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	4.8% 3/62 • Number of events 4 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	3.3% 4/122 • Number of events 5 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.

Other adverse events

Other adverse events
Measure	Simultaneous 1st, Optimized 2nd n=60 participants at risk Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.	Optimized 1st, Simultaneous 2nd n=62 participants at risk Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.	Total Subjects n=122 participants at risk Total subjects enrolled in study.
Cardiac disorders Worsening heart failure	6.7% 4/60 • Number of events 4 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	12.9% 8/62 • Number of events 9 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	9.8% 12/122 • Number of events 13 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.
Cardiac disorders Other cardiac symptom	5.0% 3/60 • Number of events 3 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	11.3% 7/62 • Number of events 8 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.	8.2% 10/122 • Number of events 11 • Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.

Additional Information

Clay Cohorn

BIOTRONIK, Inc.

Phone: 503-387-2614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place