Attain Stability™ Quad Clinical Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03099655
• Collaborator: (none)
• Enrollment: 471
• Locations: 50
• Arm: 1
• Actual Duration (Months): 22.8
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Attain Stability Quad Left Ventricular Pacing Lead	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 471 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Attain Stability™ Quad Clinical Study
• Actual Study Start Date: Jul 7, 2017
• Actual Primary Completion Date: Aug 2, 2018
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Attain Stability Quad Lead Attain Stability Quad Lead (Model 4798) - Single arm study.	Device: Attain Stability Quad Left Ventricular Pacing Lead; cardiac stimulation; Other Names: 4798 Lead

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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%.

3. 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 Outcome Measures

1. Implant Success [During procedure]

   Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure

2. 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.

3. 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.

4. 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

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)

• Patient is unable to tolerate an urgent thoracotomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Cardiovascular Research Group, LLC	Phoenix	Arizona	United States	85006
2	Sequoia Hospital	East Palo Alto	California	United States	94062
3	Torrance Memorial Medical Center	Torrance	California	United States	90505
4	Hartford Hospital	Hartford	Connecticut	United States	06102
5	Yale New Haven Hospital	New Haven	Connecticut	United States	06520
6	Baptist Heart Specialists Pavilion Office	Jacksonville	Florida	United States	32216
7	Emory University Hospital	Atlanta	Georgia	United States	30308
8	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
9	Prairie Education & Research Cooperative (Springfield IL)	Springfield	Illinois	United States	62701
10	Iowa Heart Center (West Des Moines IA)	West Des Moines	Iowa	United States	50266
11	Delmarva Heart Research Foundation Inc	Salisbury	Maryland	United States	21804
12	DLP Marquette Physicians Practices Inc	Marquette	Michigan	United States	49855
13	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
14	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota	United States	56303
15	HealthPartners Institute (Saint Louis Park MN)	Saint Louis Park	Minnesota	United States	55426
16	Morristown Memorial Hospital	Morristown	New Jersey	United States	07960
17	The Valley Hospital	Ridgewood	New Jersey	United States	07450
18	Lourdes Cardiology Services	Voorhees	New Jersey	United States	08043
19	Asheville Cardiology Associates	Asheville	North Carolina	United States	28803
20	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
21	Duke University Medical Center (DUMC)	Durham	North Carolina	United States	27710
22	The Lindner Research Center	Cincinnati	Ohio	United States	45219
23	Cleveland Clinic	Cleveland	Ohio	United States	44195
24	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
25	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma	United States	73120
26	Oklahoma Heart Institute	Tulsa	Oklahoma	United States	74104
27	Sutherland Cardiology Clinic	Memphis	Tennessee	United States	38103
28	Centennial Heart Cardiovascular Consultants L	Nashville	Tennessee	United States	37203
29	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
30	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
31	Baylor Research Institute (Plano TX)	Dallas	Texas	United States	75226
32	CHI Saint Luke's Health - Baylor Saint Luke's Medical Center	Houston	Texas	United States	77030
33	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
34	Kootenai Heart Clinics Northwest	Spokane	Washington	United States	99204
35	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
36	University of Calgary	Calgary		Canada	T2N 4N1
37	London Health Sciences Centre - University Campus	London		Canada	N6A 5A5
38	Southlake Regional Health Centre	Newmarket		Canada	L3Y 8C3
39	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec		Canada	G1V 4G5
40	Klinik für Herzchirurgie Karlsruhe	Karlsruhe		Germany	76185
41	Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH	Lüdenscheid		Germany	58515
42	Prince of Wales Hospital	Hong Kong		Hong Kong
43	Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello	Pisa		Italy	56100
44	Institut Jantung Negara - National Heart Institute	Kuala Lumpur		Malaysia	50400
45	Catharina Ziekenhuis	Eindhoven		Netherlands	5623 EJ
46	Isala Zwolle	Zwolle		Netherlands	8011 JW
47	Helse Bergen HF - Haukeland Universitetssjukehus	Bergen		Norway	5021
48	Hospital Universitario Ramón y Cajal	Madrid		Spain	28050
49	Hospital Clínico Universitario de Valladolid	Valladolid		Spain	47006
50	Karolinska Universitetssjukhuset	Stockholm		Sweden	17176

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: George Crossley III, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Statistical Analysis Plan - Jul 25, 2017
• Study Protocol - Mar 20, 2017

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT03099655
• Other Study ID Numbers: Attain Stability Quad
• First Posted: Apr 4, 2017
• Last Update Posted: Jan 9, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Heart Failure; Cardiac Pacing; Cardiac Resynchronization Therapy; Left Ventricular Lead
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Pre-assignment Detail	Out of 471 initial enrollments;31 were excluded due to the following: No implant attempted(23) Investigator deemed not medically necessary(4) Insurance declined coverage(2) Patient did not meet criteria for the study(1) Investigator withdrew, not a good candidate(1) Resulting in 440 subjects with 4798 Lead implant attempted

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	Attain Stability Quad Lead (Model 4798) - Single arm study. Attain Stability Quad Left Ventricular Pacing Lead: cardiac stimulation
Period Title: Overall Study
STARTED	440
COMPLETED	379
NOT COMPLETED	61

Baseline Characteristics

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
Overall Participants	440
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (11)
Sex: Female, Male (Count of Participants)
Female	111 25.2%
Male	329 74.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%
Asian	26 5.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	28 6.4%
White	312 70.9%
More than one race	0 0%
Unknown or Not Reported	73 16.6%
Region of Enrollment (participants) [Number]
Canada	37 8.4%
Netherlands	23 5.2%
Sweden	3 0.7%
Hong Kong	1 0.2%
United States	314 71.4%
Norway	15 3.4%
Italy	3 0.7%
Malaysia	23 5.2%
Germany	12 2.7%
Spain	9 2%

Outcome Measures

1. Primary Outcome

Title	Lead Complication-free Rate at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
Measure Participants	440
Number (97.5% Confidence Interval) [Survival Probability (% of subjects)]	97.59

2. Primary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	All subjects who are successfully implanted with Model 4798 lead and with valid pacing data collected at 6 months post-implant follow-up visit.
Measure Participants	377
Number (97.5% Confidence Interval) [Percent of Subjects]	96.29

3. Primary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Attain Stability Quad Lead
Arm/Group Description	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
Measure Participants	377
Number (97.5% Confidence Interval) [Percent of Subjects]	94.16

4. Secondary Outcome

Title	Implant Success
Description	Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure
Time Frame	During procedure

Outcome Measure Data

Analysis Population Description

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
Measure Participants	440
Number (95% Confidence Interval) [Percent of Subjects]	96.8

5. Secondary Outcome

Title	Implant Duration
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.
Measure Participants	426
Implant Procedure Time	93 (40)
Fluoroscopy	19 (15)
Cannulation	7 (11)

6. Secondary Outcome

Title	LV Pacing Capture Threshold (PCT) at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.
Measure Participants	426
Mean (Standard Deviation) [Volts]	1.07 (0.68)

7. Secondary Outcome

Title	LV Impedance at 6 Months
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected at 6 months post implant follow-up visit.
Measure Participants	426
Mean (Standard Deviation) [Ohms]	557.7 (179.5)

8. Secondary Outcome

Title	Post Implant Lead Failure Rate
Description	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

Outcome Measure Data

Analysis Population Description

Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.

Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	All subjects who are successfully implanted with a Model 4798 lead.
Measure Participants	426
Device Connection Issue	0.23
Device Pacing Issue	0.23
Device Stimulation Issue	0.70
Lead Dislodgement	0.70
Infection	0.23
Ventricular Tachycardia	0.23

Adverse Events

Time Frame	Date of implant (or attempted implant) through study completion, an average of 6.42 months.
Arm/Group Title	Attain Stability Quad Lead
Arm/Group Description	Patients with an implant attempt for the Attain Stability Quad Lead (Model 4798)
All Cause Mortality
	Attain Stability Quad Lead
	Affected / at Risk (%)	# Events
Total	22/440 (5%)
Serious Adverse Events
	Attain Stability Quad Lead
	Affected / at Risk (%)	# Events
Total	147/440 (33.4%)
Blood and lymphatic system disorders
Anaemia	7/440 (1.6%)	8
Haemorrhagic anaemia	1/440 (0.2%)	1
Iron deficiency anaemia	1/440 (0.2%)	1
Thrombocytopenia	1/440 (0.2%)	1
Cardiac disorders
Acute left ventricular failure	1/440 (0.2%)	1
Acute myocardial infarction	3/440 (0.7%)	4
Angina pectoris	1/440 (0.2%)	1
Aortic valve stenosis	1/440 (0.2%)	1
Atrial fibrillation	16/440 (3.6%)	17
Atrial flutter	3/440 (0.7%)	3
Bradycardia	1/440 (0.2%)	1
Cardiac arrest	4/440 (0.9%)	4
Cardiac failure	11/440 (2.5%)	12
Cardiac failure acute	18/440 (4.1%)	21
Cardiac failure chronic	1/440 (0.2%)	1
Cardiac failure congestive	15/440 (3.4%)	17
Cardiac perforation	1/440 (0.2%)	1
Cardiac tamponade	1/440 (0.2%)	1
Hypertensive heart disease	1/440 (0.2%)	1
Palpitations	1/440 (0.2%)	1
Pericardial effusion	2/440 (0.5%)	2
Pericarditis	1/440 (0.2%)	1
Pulseless electrical activity	1/440 (0.2%)	2
Ventricular extrasystoles	1/440 (0.2%)	1
Ventricular fibrillation	1/440 (0.2%)	1
Ventricular tachycardia	9/440 (2%)	9
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation	1/440 (0.2%)	1
Ear and labyrinth disorders
Inner ear disorder	1/440 (0.2%)	1
Eye disorders
Retinal artery occlusion	1/440 (0.2%)	1
Gastrointestinal disorders
Abdominal pain upper	1/440 (0.2%)	1
Constipation	1/440 (0.2%)	1
Diarrhoea	1/440 (0.2%)	1
Femoral hernia incarcerated	1/440 (0.2%)	1
Gastrointestinal haemorrhage	6/440 (1.4%)	6
Inguinal hernia	1/440 (0.2%)	1
Inguinal hernia, obstructive	1/440 (0.2%)	1
Upper gastrointestinal haemorrhage	3/440 (0.7%)	3
General disorders
Death	1/440 (0.2%)	1
Hernia	1/440 (0.2%)	1
Implant site haematoma	8/440 (1.8%)	8
Implant site pain	1/440 (0.2%)	1
Non-cardiac chest pain	4/440 (0.9%)	4
Sudden cardiac death	1/440 (0.2%)	1
Hepatobiliary disorders
Cholecystitis acute	1/440 (0.2%)	1
Cholelithiasis	1/440 (0.2%)	1
Immune system disorders
Amyloidosis	1/440 (0.2%)	1
Infections and infestations
Bacteraemia	1/440 (0.2%)	1
Bronchitis	1/440 (0.2%)	1
Cellulitis	3/440 (0.7%)	4
Diverticulitis	1/440 (0.2%)	1
Gangrene	1/440 (0.2%)	1
Implant site infection	2/440 (0.5%)	2
Influenza	1/440 (0.2%)	1
Lower respiratory tract infection	1/440 (0.2%)	1
Osteomyelitis	1/440 (0.2%)	1
Periorbital cellulitis	1/440 (0.2%)	1
Pneumococcal sepsis	1/440 (0.2%)	1
Pneumonia	9/440 (2%)	10
Pneumonia viral	1/440 (0.2%)	1
Pyelitis	1/440 (0.2%)	1
Sepsis	2/440 (0.5%)	2
Septic shock	3/440 (0.7%)	3
Staphylococcal bacteraemia	1/440 (0.2%)	1
Staphylococcal sepsis	1/440 (0.2%)	1
Urinary tract infection	5/440 (1.1%)	6
Injury, poisoning and procedural complications
Cardiac vein perforation	1/440 (0.2%)	1
Femoral neck fracture	3/440 (0.7%)	3
Femur fracture	1/440 (0.2%)	1
Incision site inflammation	1/440 (0.2%)	1
Lumbar vertebral fracture	1/440 (0.2%)	1
Meniscus injury	1/440 (0.2%)	1
Post procedural haematoma	1/440 (0.2%)	1
Rib fracture	1/440 (0.2%)	1
Road traffic accident	1/440 (0.2%)	1
Subarachnoid haemorrhage	1/440 (0.2%)	1
Toxicity to various agents	1/440 (0.2%)	1
Investigations
Clostridium test positive	1/440 (0.2%)	2
International normalised ratio increased	1/440 (0.2%)	1
White blood cell count increased	1/440 (0.2%)	1
Metabolism and nutrition disorders
Dehydration	2/440 (0.5%)	2
Hyponatraemia	1/440 (0.2%)	1
Hypovolaemia	2/440 (0.5%)	2
Obesity	1/440 (0.2%)	1
Musculoskeletal and connective tissue disorders
Gouty arthritis	1/440 (0.2%)	1
Osteoarthritis	1/440 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	2/440 (0.5%)	2
Metastases to spinal cord	1/440 (0.2%)	1
Nervous system disorders
Cerebrovascular accident	1/440 (0.2%)	1
Encephalopathy	1/440 (0.2%)	1
Metabolic encephalopathy	1/440 (0.2%)	1
Presyncope	1/440 (0.2%)	1
Seizure	1/440 (0.2%)	1
Spinal cord compression	1/440 (0.2%)	1
Syncope	4/440 (0.9%)	5
Product Issues
Device connection issue	1/440 (0.2%)	1
Device inappropriate shock delivery	1/440 (0.2%)	1
Device pacing issue	3/440 (0.7%)	3
Device stimulation issue	3/440 (0.7%)	3
Lead dislodgement	12/440 (2.7%)	12
Oversensing	2/440 (0.5%)	2
Renal and urinary disorders
Acute kidney injury	10/440 (2.3%)	11
End stage renal disease	1/440 (0.2%)	1
Haematuria	1/440 (0.2%)	1
Nephropathy	1/440 (0.2%)	1
Renal impairment	1/440 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	2/440 (0.5%)	2
Chronic obstructive pulmonary disease	2/440 (0.5%)	2
Epistaxis	1/440 (0.2%)	1
Haemoptysis	1/440 (0.2%)	1
Pleural effusion	2/440 (0.5%)	2
Pneumonia aspiration	3/440 (0.7%)	3
Pneumothorax	1/440 (0.2%)	1
Pulmonary embolism	2/440 (0.5%)	2
Respiratory failure	2/440 (0.5%)	2
Surgical and medical procedures
Medical device change	2/440 (0.5%)	2
Vascular disorders
Dry gangrene	1/440 (0.2%)	1
Femoral artery embolism	1/440 (0.2%)	1
Hypertensive emergency	1/440 (0.2%)	1
Hypotension	5/440 (1.1%)	5
Intermittent claudication	2/440 (0.5%)	3
Peripheral arterial occlusive disease	1/440 (0.2%)	1
Peripheral ischaemia	1/440 (0.2%)	1
Peripheral vascular disorder	1/440 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Attain Stability Quad Lead
	Affected / at Risk (%)	# Events
Total	27/440 (6.1%)
Product Issues
Device stimulation issue	27/440 (6.1%)	31

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.