ALternate Site Cardiac ReSYNChronization (ALSYNC) Study (ALSYNC)

Tracking Information
First Submitted Date ICMJE	January 11, 2011
First Posted Date ICMJE	January 17, 2011
Last Update Posted Date	June 19, 2013
Study Start Date ICMJE	January 2011
Estimated Primary Completion Date	April 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 14, 2012)	Percentage of patients free from lead, delivery system and implant related complications. [ Time Frame: Six months ]
Original Primary Outcome Measures ICMJE; (submitted: January 14, 2011)	Percentage of patients free from lead, delivery system and implant related complications [ Time Frame: Six months ]
Change History	Complete list of historical versions of study NCT01277783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 14, 2012)	Percentage of patients with successful lead implant in the Left Ventricle via a superior approach. [ Time Frame: 6 Months ]; Ease of positioning the SelectSecure® Model 3830 using the Models 6227ATS, 6248HS, JS, or JL catheters. [ Time Frame: 6 Months ]To evaluate the ease of positioning of the above lead and catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent will be used.; Left Ventricular pacing voltage threshold at 0.4 ms pulse width. [ Time Frame: 12 months ]; Left Ventricular sensed R-wave amplitude. [ Time Frame: 12 months ]; Left Ventricular pacing impedance. [ Time Frame: 12 months ]; Change in NYHA Class. [ Time Frame: 6 months ]; Change in 6 minute hallwalk. [ Time Frame: 12 Months ]; Change in Left Ventricular End-Systolic Volume. [ Time Frame: 6 months ]; Change in Left Ventricular Ejection Fraction. [ Time Frame: 6 months ]; Change in Left Ventricular End-Diastolic Diameter. [ Time Frame: 6 months ]; Change in Mitral Regurgitation. [ Time Frame: 6 months ]; Change in Brain Natriuretic Peptide (BNP)/N-Terminal-prohormone BNP levels. [ Time Frame: 6 months ]
Original Secondary Outcome Measures ICMJE; (submitted: January 14, 2011)	Percentage of patients with successful lead implant in the Left Ventricle via a superior approach. [ Time Frame: 6 Months ]; Ease of positioning the SelectSecure® Model 3830 using the Models 6227ATS, 6248HS, JS, or JL catheters. [ Time Frame: 6 Months ]; Chracterize Left Ventricular pacing voltage threshold at 0.4 ms pulse width using descriptive statistics [ Time Frame: 12 months ]; Chracterize Left Ventricular sensed R-wave amplitude using descriptive statistics [ Time Frame: 12 months ]; Characterize Left Ventricular pacing impedance using descriptive statistics [ Time Frame: 12 months ]; Change in NYHA Class [ Time Frame: 6 months ]; Change in 6 minute hallwalk [ Time Frame: 12 Months ]; Change in Left Ventricular End-Systolic Volume [ Time Frame: 6 months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
Official Title ICMJE	ALternate Site Cardiac ReSYNChronization Study
Brief Summary	The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation. The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Heart Failure
Intervention ICMJE	Device: Medtronic Model 6227ATS deflectable delivery catheter Endocardial Left Ventricular pacing lead delivery; Device: Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter Endocardial Left Ventricular pacing lead delivery; Device: Medtronic Model 3830 Endocardial Left Ventricular pacing
Study Arms	Not Provided
Publications *	Biffi M, Defaye P, Jaïs P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.; Morgan JM, Biffi M, Gellér L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: January 14, 2011)	130
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2014
Estimated Primary Completion Date	April 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Cardiac Resynchronization Therapy candidate/recipient with:; Failed Cardiac Resynchronization Therapy implant or required CRT replacement without viable access to Coronary sinus or,; Sub-optimal Coronary sinus anatomy per investigator discretion or,; Worsened or unchanged clinical status after Cardiac Resynchronization Therapy implant; Patients able and willing to take optimal Vitamin K antagonist therapy (INR of 2-4); Patients willing to sign and date the Patient Informed Consent form; Patients 18 years of age or older; Patients able and willing to comply with the protocol, and is expected to remain available for follow-up visits Exclusion Criteria: Patients having contraindications to Vitamin K antagonist therapy; Patients contraindicated for < 100 micrograms beclomethasone dipropionate; Patients unable to tolerate an urgent thoracotomy; Documented (previous) ischemic or hemorrhagic stroke; Patients with known previous atrial septal defect closure, or history of mural thrombus that has not been resolved; Patients with documented atrial fibrillation AND increased stroke risk as determined by the Congestive Heart Failure, Hypertension, Age(2), Diabetes, Stroke(2), Vascular disease, Age, and Sex Category (CHA2DS2-VASc) Score of equal to or greater than 5; Patients with unstable angina pectoris or who have had an acute myocardial infarct within the past 30 days; Patients with known ASD and/or left superior vena cava; Patient with known internal carotid artery stenosis of greater than 50%; Patients diagnosed with peripheral artery disease that are expected to undergo stenting within the next three months; Patients who have had a Coronary artery bypass graft or stent within the past three months; Patients with history of mitral or aortic valve repair or replacement; Post heart transplant patients (patients waiting for heart transplant are allowed in the study); Patients currently undergoing dialysis treatment; Patients with ongoing chemotherapy and radiation therapy that may have an effect on cardiac function; Patients with ongoing Adverse Events from a previous Left Ventricle lead implant attempt; Patients enrolled in any concurrent drug and/or device study that may confound the results of this study; Patients who are not expected to survive more than twelve months; Patients with exclusion criteria required by local law
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Canada, France, Hungary, Italy, Netherlands, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01277783
Other Study ID Numbers ICMJE	ALSYNC
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor ICMJE	Medtronic Cardiac Rhythm and Heart Failure
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Professor John Morgan, MA MD FRCP FESC Spire Southampton Hospital
PRS Account	Medtronic Cardiac Rhythm and Heart Failure
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP