ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

NCT01277783 | Completed Results DMC

• 1 other identifier: ALSYNC
• Study Type: interventional
• Target: 138
• Locations: 7 countries
• Sites: 18

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.

  Adverse events were reviewed by an independent Adverse Event Adjudication Committee. Events classified as complication related to the LV endocardial lead, the investigational delivery system or the implant procedure contribute to the outcome. The percentage of patients free from such complication at 6 months after the procedure was estimated using the Kaplan-Meier method and is reported with the corresponding 95% confidence interval.

  6 months

Secondary Outcomes (12)

• Implant Success

  Implant

• Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor

  Implant

• Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months

  12 months

• Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months

  12 months

• Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months

  12 months

Study Arms (1)

Endocardial Left Ventricular pacing

EXPERIMENTAL

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.

Device: Endocardial Left Ventricular pacing

Interventions

Endocardial Left Ventricular pacing 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.

Endocardial Left Ventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (18)

AZ Sint-Jan - Campus Sint-Jan

Bruges, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Location

Saint Paul's Hospital

Vancouver, British Columbia, Canada

Location

London Health Sciences Centre - University Campus

London, Ontario, Canada

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, France

Location

CHU Grenoble Hôpital Michalon

Grenoble, France

Location

Infirmerie Protestante de Lyon

Lyon, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

Hôpital Pontchaillou - CHU de Rennes

Rennes, France

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

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

Bologna, Italy

Location

Presidio Ospedaliero Alessandro Manzoni

Lecco, Italy

Location

Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri

Roma, Italy

Location

Academisch Ziekenhuis Maastricht (AZM)

Maastricht, Netherlands

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

University College London Hospitals NHS Foundation Trust - The Heart Hospital

London, United Kingdom

Location

Southampton General Hospital

Southhampton, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29579617 DERIVED

• 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.

  PMID: 26787437 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Mireille van Ginneken, Principal Clinical Research Specialist
• Organization: Medtronic Bakken Research Center B.V.

mireille.vanginneken@medronic.com

+31433566801

Study Officials

• Professor John Morgan, MD

  Spire Southampton Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 17, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); IT (3); CA (2); FR (5); BE (2); HU (1); NL (1)