The purpose of this clinical trial is to evaluate the post-implant safety and efficacy of the Medtronic Attain Performa Quadripolar Model 4298, Model 4398, and Model 4598 Left Ventricular (LV) leads (*Attain Performa leads*) and also assess and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Objective
• Attain Performa Safety Objective: Lead complication-free rate at 6 months
The Attain Performa lead will be considered safe if the proportion of subjects
free of Attain Performa lead-related complications at 6 months post-implant is
greater than 87% (i.e., the two-sided 95% lower confidence bound must be
greater than 87%).
Primary Efficacy Objectives
The effectiveness of the lead will be evaluated based on two primary efficacy
endpoints. The lead will be considered effective if both primary efficacy
objectives are met simultaneously. The primary efficacy endpoints include
pacing threshold assessments for the final programmed LV pacing configuration
and for one additional programmable (non-programmed) pacing configuration while
at least one of these two configurations must be a non-standard pacing vector.
• Attain Performa lead Efficacy Objective #1
The Attain Performa lead will be considered effective if the proportion of
subjects with final programmed pacing vector having pacing voltage threshold
less than or equal to 2.5 V at 0.5ms pulse width at 6 months post-implant is
greater than 80% (i.e., the two-sided 95% lower confidence bound must be
greater than 80%).
• Attain Performa lead Efficacy Objective #2
The Attain Performa lead will be considered effective if the proportion of
subjects with a non-programmed pacing vector having a pacing voltage threshold
less than or equal to 4.0 V at 0.5ms pulse width at 6 months post-implant is
greater than 80% (i.e., the two-sided 95% lower confidence bound must be
greater than 80%).
Secondary outcome
Secondary Objectives
• Evaluate occurrences of PNS in all LV configurations, which will require:
1) Testing for presence of PNS at 8.0 V at 0.5ms performed at pre-hospital
discharge, 3 months, 6 months, and 12 months post-implant for all LV lead
vectors
2) Testing for PNS thresholds at 6 months and 12 months post-implant for all LV
lead vectors where PNS is present at 8.0 V at 0.5ms
3) Assessment of all adverse events (AEs) for PNS that occur throughout study
duration
• Summarize implant success rates
• Evaluate the following implant-related times: total implant, standard
fluoroscopy, coronary sinus cannulation and successful lead placement
• Evaluate the handling characteristics of the Attain Performa leads
• Characterize the electrical performance of multiple pacing configurations (LV
pacing capture threshold (PCT), sensing, impedance, and PNS) of the Attain
Performa leads at pre-hospital discharge, 1 month, 3 months, 6, months, and
every 6 months thereafter until study closure
• Characterize all AEs
• Characterize system related complications
• Estimate individual failure rate through 6 months post-implant
Background summary
Various LV lead models have been designed to suit the various sizes and shapes
of patients* cardiac venous anatomies and implanting physician preferences.
Despite advancements in LV lead technology, occasionally invasive post-implant
interventions related to the LV lead may be required due to problems with high
pacing thresholds, lead dislodgement or phrenic nerve stimulation (PNS) which
might be important causes of failure to deliver CRT. Recent development of
dual and quadripolar electrode LV leads has improved LV lead management by
providing more options for ensuring chronic pacing with an acceptable threshold
value, avoiding PNS occurrence by changing pacing configuration and termination
of CRT therapy as well as reducing the risk of invasive treatments.
Study objective
The purpose of this clinical trial is to evaluate the post-implant safety and
efficacy of the Medtronic Attain Performa Quadripolar Model 4298, Model 4398,
and Model 4598 Left Ventricular (LV) leads (*Attain Performa leads*) and also
assess and characterize their interaction with a Viva Quad Cardiac
Resynchronization Therapy device (see Study Components section for details)
with defibrillation capabilities (CRT-D) in patients indicated for a CRT-D
device.
Study design
The Attain Performa* Quadripolar Lead Clinical Study is a prospective,
non-randomized, multi-center, single arm, Investigational Device Exemption
(IDE) clinical trial.
The Model 4298, Model 4398, and Model 4598 LV leads will be studied in this
clinical trial, although the three lead models will be evaluated independently
and will have separate study reports and regulatory submissions. The study
objectives for the three lead models will be identical and will investigate the
safety and efficacy of the investigational leads along with an assessment of
the overall system safety.
Subjects successfully implanted with an Attain Performa lead, Viva Quad CRT-D
device, and Medtronic RV lead with DF4 connector will be followed at implant,
pre-hospital discharge (PHD), 1 month, 3 months, 6 months and every 6 months
thereafter until FDA approval is obtained or until study closure, whichever
comes first. For this study, all system-related, procedure-related,
cardiovascular-related and Serious Adverse Event information will be collected.
Intervention
Implantation with an Attain Performa lead, Viva Quad CRT-D device, and
Medtronic RV lead with DF4 connector.
Study burden and risks
Risks assiciated with the LV implantation are compareble with every other LV
lead implantation.
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Earl Bakkenstraat 10
Heerlen 6422 PJ
NL
Listed location countries
Age
Inclusion criteria
Patient has an indication for a CRT-D device.
Exclusion criteria
Patient has contraindications for standard transvenous cardiac pacing.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | bekend na FDA approval |
| CCMO | NL41967.060.12 |