Trial Outcomes & Findings for Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT) (NCT NCT01520714)

NCT ID: NCT01520714

Last Updated: 2014-05-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-05-26

Participant Flow

Patients required at physician office. Recruiting will be active until 40 patients are randomized.

Participant milestones

Measure	Medtronic Passive Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.	Medtronic 4195 Active Fixation LV Lead Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
Overall Study STARTED	0	11
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Measure	Medtronic Passive Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.	Medtronic 4195 Active Fixation LV Lead Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
Overall Study Protocol Violation	0	3
Overall Study Adverse Event	0	2
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

Baseline characteristics by cohort

Measure	Medtronic Passive Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.	Medtronic 4195 Active Fixation LV Lead n=11 Participants Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	7 participants n=7 Participants	7 participants n=5 Participants
Age, Categorical >=65 years	—	4 participants n=7 Participants	4 participants n=5 Participants
Age, Continuous	—	65 years STANDARD_DEVIATION 11 • n=7 Participants	65 years STANDARD_DEVIATION 11 • n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	10 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment United States	—	11 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.

Outcome measures

Outcome data not reported

Adverse Events

Medtronic 4195 Active Fixation LV Lead

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Medtronic Passive Fixation LV Lead

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Medtronic 4195 Active Fixation LV Lead n=11 participants at risk Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.	Medtronic Passive Fixation LV Lead Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
Cardiac disorders Pre-existing AF-AVNode ABL	9.1% 1/11 • Number of events 1 • 1 year	— 0/0 • 1 year
Blood and lymphatic system disorders Enteroccoccal Septicemia	9.1% 1/11 • Number of events 1 • 1 year	— 0/0 • 1 year
Cardiac disorders LV lead dislodgement	9.1% 1/11 • Number of events 1 • 1 year	— 0/0 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Research Manager

The Heart Hospital Baylor Plano

Phone: 469-814-4712

Email: natalie.settele@baylorhealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place