Attain Stability™ Quad Clinical Study

Heart Failure Clinical Trial

Official title:

Attain Stability™ Quad Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099655
• Other study ID #: Attain Stability Quad
• Status: Completed
• Phase: N/A
• Start date: July 7, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: May 31, 2019
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Attain Stability Quad Left Ventricular Pacing Lead
cardiac stimulation

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary
Canada	London Health Sciences Centre - University Campus	London
Canada	Southlake Regional Health Centre	Newmarket
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Quebec
Germany	Klinik für Herzchirurgie Karlsruhe	Karlsruhe
Germany	Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH	Lüdenscheid
Hong Kong	Prince of Wales Hospital	Hong Kong
Italy	Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello	Pisa
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Isala Zwolle	Zwolle
Norway	Helse Bergen HF - Haukeland Universitetssjukehus	Bergen
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Sweden	Karolinska Universitetssjukhuset	Stockholm
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	The Lindner Research Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Research Institute (Plano TX)	Dallas	Texas
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Sequoia Hospital	East Palo Alto	California
United States	Hartford Hospital	Hartford	Connecticut
United States	CHI Saint Luke's Health - Baylor Saint Luke's Medical Center	Houston	Texas
United States	Baptist Heart Specialists Pavilion Office	Jacksonville	Florida
United States	DLP Marquette Physicians Practices Inc	Marquette	Michigan
United States	Sutherland Cardiology Clinic	Memphis	Tennessee
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Centennial Heart Cardiovascular Consultants L	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	Phoenix Cardiovascular Research Group, LLC	Phoenix	Arizona
United States	The Valley Hospital	Ridgewood	New Jersey
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	HealthPartners Institute (Saint Louis Park MN)	Saint Louis Park	Minnesota
United States	Delmarva Heart Research Foundation Inc	Salisbury	Maryland
United States	Kootenai Heart Clinics Northwest	Spokane	Washington
United States	Prairie Education & Research Cooperative (Springfield IL)	Springfield	Illinois
United States	Torrance Memorial Medical Center	Torrance	California
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center (West Des Moines IA)	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hong Kong,  Italy,  Malaysia,  Netherlands,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Implant to 6 months post-implant
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%.	6 months post-implant
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%.	6 months post-implant
Secondary	Implant Success	Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure	During procedure
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.	During procedure
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.	Implant to 6 months post-implant
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	Implant to 6 months
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	Implant to 6 months