ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

NCT ID: NCT01277783

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-10-31

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

Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure decompensation and improves quality of life in indicated patients. However, many do not benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%) or lack of symptomatic improvement (30-40%).

The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial (LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead delivery system.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocardial Left Ventricular pacing

All patients will undergo the intervention, and are followed at 1, 3, 6, and 12 months (minimum) and biannually thereafter until 1 year after enrollment of the last patient.

Group Type: EXPERIMENTAL

Endocardial Left Ventricular pacing

Intervention Type: DEVICE

Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure.

Interventions

Endocardial Left Ventricular pacing

Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure.

Intervention Type: DEVICE

Eligibility Criteria

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 (International Normalized Ratio (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 atrial septum defect (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor John Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

Spire Southampton Hospital

Locations

AZ Sint-Jan - Campus Sint-Jan

Bruges, , Belgium

Centre Hospitalier Regional de la Citadelle

Liège, , Belgium

Saint Paul's Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre - University Campus

London, Ontario, Canada

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, , France

CHU Grenoble Hôpital Michalon

Grenoble, , France

Infirmerie Protestante de Lyon

Lyon, , France

Nouvelles Cliniques Nantaises

Nantes, , France

Hôpital Pontchaillou - CHU de Rennes

Rennes, , France

Semmelweis Egyetem AOK

Budapest, , Hungary

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi

Bologna, , Italy

Presidio Ospedaliero Alessandro Manzoni

Lecco, , Italy

Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri

Roma, , Italy

Academisch Ziekenhuis Maastricht (AZM)

Maastricht, , Netherlands

Royal Victoria Hospital

Belfast, , United Kingdom

Golden Jubilee National Hospital

Glasgow, , United Kingdom

University College London Hospitals NHS Foundation Trust - The Heart Hospital

London, , United Kingdom

Southampton General Hospital

Southhampton, , United Kingdom

Countries

Belgium; Canada; France; Hungary; Italy; Netherlands; United Kingdom

References

Biffi M, Defaye P, Jais 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.

Reference Type: DERIVED

PMID: 29579617 (View on PubMed)

Morgan JM, Biffi M, Geller 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.

Reference Type: DERIVED

PMID: 26787437 (View on PubMed)

Other Identifiers

ALSYNC

Identifier Type: -

Identifier Source: org_study_id