Heart Failure
Conditions
Keywords
Heart Failure, Cardiac Pacing, Cardiac Resynchronization Therapy, Left Ventricular Lead
Brief summary
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
Detailed description
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, investigational Device Exemption (IDE), interventional clinical study. The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary efficacy endpoints. All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an Attain Stability Quad MRI SureScan LV Lead (Model 4798). Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15% attrition) at up to 56 sites worldwide.
Interventions
DEVICEAttain Stability Quad Left Ventricular Pacing Lead
cardiac stimulation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV lead. This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead (Model 20066/4796) (available outside of the United States).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines) * Patient (or legally authorized representative) has signed and dated the study-specific Informed Consent Form * Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law * Patient is expected to remain available for follow-up visits
Exclusion criteria
* Patient has had a previous unsuccessful LV lead implant attempt * Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial) * Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA and/or RV lead * Patient has known coronary venous vasculature that is inadequate for lead placement * Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days * Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 90 days * Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) * Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study) * Patient has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure * Patient is contraindicated for \<1mg dexamethasone acetate * Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study * Patient has a terminal illness and is not expected to survive more than six months * Patient meets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lead Complication-free Rate at 6 Months | Implant to 6 months post-implant | Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention. Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee. |
| Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) | 6 months post-implant | The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V. -Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%. |
| Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) | 6 months post-implant | The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy. -Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LV Impedance at 6 Months | Implant to 6 months | Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject |
| Implant Success | During procedure | Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure |
| Post Implant Lead Failure Rate | Implant to 6 months | Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure |
| Implant Duration | During procedure | Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure. |
| LV Pacing Capture Threshold (PCT) at 6 Months | Implant to 6 months post-implant | Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit. |
Countries
Canada, Germany, Hong Kong, Italy, Malaysia, Netherlands, Norway, Spain, Sweden, United States
Participant flow
Pre-assignment details
Out of 471 initial enrollments;31 were excluded due to the following: 1. No implant attempted(23) 2. Investigator deemed not medically necessary(4) 3. Insurance declined coverage(2) 4. Patient did not meet criteria for the study(1) 5. Investigator withdrew, not a good candidate(1) Resulting in 440 subjects with 4798 Lead implant attempted
Participants by arm
| Arm | Count |
|---|---|
| Attain Stability Quad Lead Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798) | 440 |
| Total | 440 |
Baseline characteristics
| Characteristic | Attain Stability Quad Lead |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 73 Participants |
| Race (NIH/OMB) White | 312 Participants |
| Region of Enrollment Canada | 37 participants |
| Region of Enrollment Germany | 12 participants |
| Region of Enrollment Hong Kong | 1 participants |
| Region of Enrollment Italy | 3 participants |
| Region of Enrollment Malaysia | 23 participants |
| Region of Enrollment Netherlands | 23 participants |
| Region of Enrollment Norway | 15 participants |
| Region of Enrollment Spain | 9 participants |
| Region of Enrollment Sweden | 3 participants |
| Region of Enrollment United States | 314 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 329 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 440 |
| other Total, other adverse events | 27 / 440 |
| serious Total, serious adverse events | 147 / 440 |
Outcome results
Primary
Lead Complication-free Rate at 6 Months
Subjects free of Model 4798 lead-related complications at 6 months post-implant -Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention. Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee.
Time frame: Implant to 6 months post-implant
Population: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Stability Quad Lead | Lead Complication-free Rate at 6 Months | 97.59 Survival Probability (% of subjects) |
Primary
Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy. -Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Time frame: 6 months post-implant
Population: All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected 6 months post-implant follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Stability Quad Lead | Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) | 94.16 Percent of Subjects |
Primary
Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)
The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V. -Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%.
Time frame: 6 months post-implant
Population: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Stability Quad Lead | Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS) | 96.29 Percent of Subjects |
Secondary
Implant Duration
Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.
Time frame: During procedure
Population: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attain Stability Quad Lead | Implant Duration | Implant Procedure Time | 93 Minutes | Standard Deviation 40 |
| Attain Stability Quad Lead | Implant Duration | Fluoroscopy | 19 Minutes | Standard Deviation 15 |
| Attain Stability Quad Lead | Implant Duration | Cannulation | 7 Minutes | Standard Deviation 11 |
Secondary
Implant Success
Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Time frame: During procedure
Population: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Stability Quad Lead | Implant Success | 96.8 Percent of Subjects |
Secondary
LV Impedance at 6 Months
Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject
Time frame: Implant to 6 months
Population: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attain Stability Quad Lead | LV Impedance at 6 Months | 557.7 Ohms | Standard Deviation 179.5 |
Secondary
LV Pacing Capture Threshold (PCT) at 6 Months
Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.
Time frame: Implant to 6 months post-implant
Population: Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attain Stability Quad Lead | LV Pacing Capture Threshold (PCT) at 6 Months | 1.07 Volts | Standard Deviation 0.68 |
Secondary
Post Implant Lead Failure Rate
Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure
Time frame: Implant to 6 months
Population: Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Device Connection Issue | 0.23 Percent of Subjects |
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Device Pacing Issue | 0.23 Percent of Subjects |
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Device Stimulation Issue | 0.70 Percent of Subjects |
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Lead Dislodgement | 0.70 Percent of Subjects |
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Infection | 0.23 Percent of Subjects |
| Attain Stability Quad Lead | Post Implant Lead Failure Rate | Ventricular Tachycardia | 0.23 Percent of Subjects |