Heart Failure
Conditions
Keywords
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
Brief summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
Interventions
DEVICEDevice: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead, separate analysis for each lead model
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines) * Patient (or legally authorized representative) has signed and dated the study-specific 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 * Patient understands the study and agrees to comply with study protocol
Exclusion criteria
* Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt * Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) * Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study) * Patient is contraindicated for \< 1 mg dexamethasone acetate * Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager) * Patient has a life expectancy less than 180 days * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lead Complication-free Rate at 6 Months | Implant to 6 months post-implant | The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: \- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa 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%). \- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models. |
| LV Pacing Capture Thresholds Per Attain Performa Lead Model | 6 months post-implant | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Implant up to 1-month post implant | — |
| Pacing Capture Thresholds at the Final Programmed Pacing Polarity | 6 months post-implant | — |
| Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | 6 months post-implant | Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit. |
| Pacing Impedance at the Final Programmed Pacing Polarity | 6 month post-implant | Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1. Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms). |
| Complication Rate for Individual Attain Performa Lead Related Events | 6 month post-Implant | — |
| Implant Related Times Per Attain Performa Lead Model | Implant up to 1-month post implant | — |
| Percentage of Subjects With Successful Implant Per Attain Performa Lead Model | Implant up to 1-month post implant | — |
Countries
Australia, Austria, Belgium, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Netherlands, Norway, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, United States
Participant flow
Pre-assignment details
Out of the 1202 Intial enrollments; 77 were excluded due to to the following pre-implant events: 1. unsuccessful cannulation (25) 2. death (3) 3. Exit prior to implant attempt (43) 4. Attain Performa Lead implant not attempted (6) Resulting in 1125 subjects with Attain Performa Lead Implant Attempts
Participants by arm
| Arm | Count |
|---|---|
| Attain Performa LV Lead Model 4298 Subjects with an attempted Attain Performa LV Lead Model 4298 implant | 499 |
| Attain Performa LV Lead Model 4398 Subjects with an attempted Attain Performa LV Lead Model 4398 implant | 326 |
| Attain Performa LV Lead Model 4598 Subjects with an attempted Attain Performa LV Lead Model 4598 implant | 300 |
| Total | 1,125 |
Baseline characteristics
| Characteristic | Attain Performa LV Lead Model 4598 | Total | Attain Performa LV Lead Model 4298 | Attain Performa LV Lead Model 4398 |
|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 11 |
| Left Ventricular Ejection Fraction (LVEF) | 27 % STANDARD_DEVIATION 7 | 26 % STANDARD_DEVIATION 7 | 25 % STANDARD_DEVIATION 7 | 26 % STANDARD_DEVIATION 7 |
| New York Heart Association Classification (NYHA) I | 4 participants | 16 participants | 8 participants | 4 participants |
| New York Heart Association Classification (NYHA) II | 89 participants | 308 participants | 125 participants | 94 participants |
| New York Heart Association Classification (NYHA) III | 198 participants | 766 participants | 352 participants | 216 participants |
| New York Heart Association Classification (NYHA) IV | 9 participants | 35 participants | 14 participants | 12 participants |
| QRS (Electrocardiogram Complex) | 156 ms STANDARD_DEVIATION 23 | 156 ms STANDARD_DEVIATION 23 | 155 ms STANDARD_DEVIATION 23 | 156 ms STANDARD_DEVIATION 24 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 participants | 9 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 17 participants | 32 participants | 7 participants | 8 participants |
| Race/Ethnicity, Customized Black or African American | 17 participants | 76 participants | 38 participants | 21 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 participants | 40 participants | 18 participants | 11 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not reportable per local laws or regulations | 48 participants | 99 participants | 30 participants | 21 participants |
| Race/Ethnicity, Customized Subject/physician chose not to provide information | 5 participants | 28 participants | 14 participants | 9 participants |
| Race/Ethnicity, Customized Two or more races | 0 participants | 4 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized White or Caucasian | 197 participants | 836 participants | 387 participants | 252 participants |
| Region of Enrollment Australia | 5 participants | 23 participants | 17 participants | 1 participants |
| Region of Enrollment Austria | 2 participants | 10 participants | 8 participants | 0 participants |
| Region of Enrollment Belgium | 5 participants | 9 participants | 3 participants | 1 participants |
| Region of Enrollment Canada | 21 participants | 60 participants | 17 participants | 22 participants |
| Region of Enrollment Chile | 0 participants | 12 participants | 12 participants | 0 participants |
| Region of Enrollment Denmark | 8 participants | 10 participants | 1 participants | 1 participants |
| Region of Enrollment Finland | 1 participants | 4 participants | 0 participants | 3 participants |
| Region of Enrollment France | 8 participants | 10 participants | 0 participants | 2 participants |
| Region of Enrollment Germany | 19 participants | 29 participants | 7 participants | 3 participants |
| Region of Enrollment Greece | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Hungary | 4 participants | 7 participants | 0 participants | 3 participants |
| Region of Enrollment India | 15 participants | 21 participants | 3 participants | 3 participants |
| Region of Enrollment Israel | 2 participants | 4 participants | 0 participants | 2 participants |
| Region of Enrollment Italy | 10 participants | 28 participants | 8 participants | 10 participants |
| Region of Enrollment Malaysia | 1 participants | 2 participants | 0 participants | 1 participants |
| Region of Enrollment Netherlands | 9 participants | 23 participants | 13 participants | 1 participants |
| Region of Enrollment Norway | 0 participants | 5 participants | 5 participants | 0 participants |
| Region of Enrollment Romania | 1 participants | 12 participants | 11 participants | 0 participants |
| Region of Enrollment Saudi Arabia | 2 participants | 17 participants | 9 participants | 6 participants |
| Region of Enrollment Serbia | 8 participants | 10 participants | 0 participants | 2 participants |
| Region of Enrollment Slovakia | 7 participants | 13 participants | 4 participants | 2 participants |
| Region of Enrollment Slovenia | 3 participants | 8 participants | 0 participants | 5 participants |
| Region of Enrollment South Africa | 2 participants | 7 participants | 3 participants | 2 participants |
| Region of Enrollment Spain | 0 participants | 4 participants | 3 participants | 1 participants |
| Region of Enrollment Switzerland | 1 participants | 4 participants | 2 participants | 1 participants |
| Region of Enrollment United Kingdom | 14 participants | 31 participants | 13 participants | 4 participants |
| Region of Enrollment United States | 152 participants | 761 participants | 360 participants | 249 participants |
| Sex: Female, Male Female | 93 Participants | 329 Participants | 143 Participants | 93 Participants |
| Sex: Female, Male Male | 207 Participants | 796 Participants | 356 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 155 / 499 | 84 / 326 | 84 / 300 |
| serious Total, serious adverse events | 218 / 499 | 134 / 326 | 117 / 300 |
Outcome results
Primary
Lead Complication-free Rate at 6 Months
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: \- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa 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%). \- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
Time frame: Implant to 6 months post-implant
Population: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Performa LV Lead Model 4298 | Lead Complication-free Rate at 6 Months | 96.04 Survival Probability (%) |
| Attain Performa LV Lead Model 4398 | Lead Complication-free Rate at 6 Months | 98.75 Survival Probability (%) |
| Attain Performa LV Lead Model 4598 | Lead Complication-free Rate at 6 Months | 96.21 Survival Probability (%) |
Primary
LV Pacing Capture Thresholds Per Attain Performa Lead Model
Time frame: 6 months post-implant
Population: Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Attain Performa LV Lead Model 4298 | LV Pacing Capture Thresholds Per Attain Performa Lead Model | 93.92 percentage of participants |
| Attain Performa LV Lead Model 4398 | LV Pacing Capture Thresholds Per Attain Performa Lead Model | 96.24 percentage of participants |
| Attain Performa LV Lead Model 4598 | LV Pacing Capture Thresholds Per Attain Performa Lead Model | 95.86 percentage of participants |
Secondary
Complication Rate for Individual Attain Performa Lead Related Events
Time frame: 6 month post-Implant
Population: Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Performa LV Lead Model 4298 | Complication Rate for Individual Attain Performa Lead Related Events | 3.70 percentage of participants |
| Attain Performa LV Lead Model 4398 | Complication Rate for Individual Attain Performa Lead Related Events | 1.58 percentage of participants |
| Attain Performa LV Lead Model 4598 | Complication Rate for Individual Attain Performa Lead Related Events | 3.74 percentage of participants |
Secondary
Implant Related Times Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Population: Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attain Performa LV Lead Model 4298 | Implant Related Times Per Attain Performa Lead Model | Cannulation | 6.3 minutes | Standard Deviation 9.5 |
| Attain Performa LV Lead Model 4298 | Implant Related Times Per Attain Performa Lead Model | Fluoroscopy | 21.7 minutes | Standard Deviation 15.4 |
| Attain Performa LV Lead Model 4298 | Implant Related Times Per Attain Performa Lead Model | LV Lead Placement | 13.0 minutes | Standard Deviation 15.9 |
| Attain Performa LV Lead Model 4298 | Implant Related Times Per Attain Performa Lead Model | Total Operation | 109.6 minutes | Standard Deviation 49 |
| Attain Performa LV Lead Model 4398 | Implant Related Times Per Attain Performa Lead Model | Total Operation | 107.96 minutes | Standard Deviation 53.46 |
| Attain Performa LV Lead Model 4398 | Implant Related Times Per Attain Performa Lead Model | Cannulation | 8.45 minutes | Standard Deviation 14.47 |
| Attain Performa LV Lead Model 4398 | Implant Related Times Per Attain Performa Lead Model | LV Lead Placement | 17.26 minutes | Standard Deviation 26.21 |
| Attain Performa LV Lead Model 4398 | Implant Related Times Per Attain Performa Lead Model | Fluoroscopy | 23.00 minutes | Standard Deviation 17.29 |
| Attain Performa LV Lead Model 4598 | Implant Related Times Per Attain Performa Lead Model | Total Operation | 95.09 minutes | Standard Deviation 43.38 |
| Attain Performa LV Lead Model 4598 | Implant Related Times Per Attain Performa Lead Model | Fluoroscopy | 18.77 minutes | Standard Deviation 12.66 |
| Attain Performa LV Lead Model 4598 | Implant Related Times Per Attain Performa Lead Model | LV Lead Placement | 11.82 minutes | Standard Deviation 14.17 |
| Attain Performa LV Lead Model 4598 | Implant Related Times Per Attain Performa Lead Model | Cannulation | 6.87 minutes | Standard Deviation 11.19 |
Secondary
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Time frame: 6 months post-implant
Population: Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attain Performa LV Lead Model 4298 | Pacing Capture Thresholds at the Final Programmed Pacing Polarity | 1.06 Volts | Standard Deviation 0.74 |
| Attain Performa LV Lead Model 4398 | Pacing Capture Thresholds at the Final Programmed Pacing Polarity | 1.15 Volts | Standard Deviation 0.76 |
| Attain Performa LV Lead Model 4598 | Pacing Capture Thresholds at the Final Programmed Pacing Polarity | 1.10 Volts | Standard Deviation 0.79 |
Secondary
Pacing Impedance at the Final Programmed Pacing Polarity
Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1. Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).
Time frame: 6 month post-implant
Population: Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to RV Coil | 460.56 Ohms | Standard Deviation 124.26 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV2 | 780.49 Ohms | Standard Deviation 228 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV3 | 776.64 Ohms | Standard Deviation 192.41 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV4 | 750.14 Ohms | Standard Deviation 171.98 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to RV Coil | 462.63 Ohms | Standard Deviation 168.82 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV3 | 562.40 Ohms | Standard Deviation 179.24 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV4 | 730.26 Ohms | Standard Deviation 196.11 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to RV Coil | 450.29 Ohms | Standard Deviation 107.29 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to LV4 | 715.20 Ohms | Standard Deviation 159.58 |
| Attain Performa LV Lead Model 4298 | Pacing Impedance at the Final Programmed Pacing Polarity | LV4 to RV Coil | 406.24 Ohms | Standard Deviation 87.12 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to RV Coil | 458.86 Ohms | Standard Deviation 110.62 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to RV Coil | 476.71 Ohms | Standard Deviation 193.46 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV4 to RV Coil | 407.17 Ohms | Standard Deviation 87.09 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV3 | 568.36 Ohms | Standard Deviation 197.87 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to LV4 | 733.30 Ohms | Standard Deviation 164.21 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV4 | 755.85 Ohms | Standard Deviation 214.04 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to RV Coil | 466.24 Ohms | Standard Deviation 123.63 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV2 | 802.52 Ohms | Standard Deviation 240.3 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV3 | 792.62 Ohms | Standard Deviation 195.78 |
| Attain Performa LV Lead Model 4398 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV4 | 761.79 Ohms | Standard Deviation 175.08 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV2 | 826.69 Ohms | Standard Deviation 275.82 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV4 | 799.70 Ohms | Standard Deviation 225.09 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to RV Coil | 468.90 Ohms | Standard Deviation 247.12 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV4 to RV Coil | 421.69 Ohms | Standard Deviation 180.51 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to RV Coil | 483.99 Ohms | Standard Deviation 247.31 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to RV Coil | 496.45 Ohms | Standard Deviation 133.92 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV4 | 756.48 Ohms | Standard Deviation 257.78 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV2 to LV3 | 580.02 Ohms | Standard Deviation 247.99 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV3 to LV4 | 740.99 Ohms | Standard Deviation 254.57 |
| Attain Performa LV Lead Model 4598 | Pacing Impedance at the Final Programmed Pacing Polarity | LV1 to LV3 | 826.15 Ohms | Standard Deviation 278.05 |
Secondary
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.
Time frame: 6 months post-implant
Population: Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV2 | 12.91 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV4 | 34.18 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV4 | 26.58 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-RV COIL | 21.52 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV2 | 38.48 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV1 | 26.58 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-RV COIL | 33.92 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV2 | 21.27 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2 -LV1 | 34.94 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV3 | 12.66 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV3 | 38.99 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV4 | 27.85 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-RV COIL | 31.39 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-RV COIL | 42.03 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV1 | 33.42 percentage of participants |
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV3 | 20.76 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV3 | 40.45 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2 -LV1 | 32.21 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-RV COIL | 44.19 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV4 | 23.60 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV4 | 34.83 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV2 | 15.36 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-RV COIL | 17.98 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV3 | 18.35 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-RV COIL | 31.84 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV1 | 24.34 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV1 | 31.46 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV4 | 25.47 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV2 | 20.22 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-RV COIL | 33.71 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV3 | 19.10 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV2 | 40.45 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV1 | 31.84 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-RV COIL | 44.57 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV2 | 35.58 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV3 | 35.58 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV1-LV4 | 37.83 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-RV COIL | 27.72 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2 -LV1 | 27.34 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV3 | 10.86 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV2-LV4 | 22.47 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-RV COIL | 24.72 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV2 | 8.61 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV3-LV4 | 18.73 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-RV COIL | 19.10 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV1 | 24.72 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV2 | 17.60 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities | LV4-LV3 | 16.10 percentage of participants |
Secondary
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Population: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attain Performa LV Lead Model 4298 | Percentage of Subjects With Successful Implant Per Attain Performa Lead Model | 97.60 percentage of participants |
| Attain Performa LV Lead Model 4398 | Percentage of Subjects With Successful Implant Per Attain Performa Lead Model | 97.55 percentage of participants |
| Attain Performa LV Lead Model 4598 | Percentage of Subjects With Successful Implant Per Attain Performa Lead Model | 98.00 percentage of participants |
Secondary
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Population: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Attain Performa LV Lead Model 4298 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Unacceptable | 0.20 percentage of participants |
| Attain Performa LV Lead Model 4298 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Acceptable | 98.00 percentage of participants |
| Attain Performa LV Lead Model 4298 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | No Response | 1.80 percentage of participants |
| Attain Performa LV Lead Model 4398 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Unacceptable | 0.31 percentage of participants |
| Attain Performa LV Lead Model 4398 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Acceptable | 98.47 percentage of participants |
| Attain Performa LV Lead Model 4398 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | No Response | 1.23 percentage of participants |
| Attain Performa LV Lead Model 4598 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Acceptable | 98.67 percentage of participants |
| Attain Performa LV Lead Model 4598 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | No Response | 1.00 percentage of participants |
| Attain Performa LV Lead Model 4598 | Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model | Unacceptable | 0.33 percentage of participants |