ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01277783
First received: January 11, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Heart Failure
Device: Medtronic Model 6227ATS deflectable delivery catheter
Device: Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter
Device: Medtronic Model 3830

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ALternate Site Cardiac ReSYNChronization Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Percentage of patients free from lead, delivery system and implant related complications. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with successful lead implant in the Left Ventricle via a superior approach. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Ease of positioning the SelectSecure® Model 3830 using the Models 6227ATS, 6248HS, JS, or JL catheters. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Left Ventricular sensed R-wave amplitude. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Left Ventricular pacing impedance. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in NYHA Class. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in 6 minute hallwalk. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End-Systolic Volume. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular Ejection Fraction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End-Diastolic Diameter. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Mitral Regurgitation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Brain Natriuretic Peptide (BNP)/N-Terminal-prohormone BNP levels. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277783

Locations
Belgium
Brugge, Belgium
Liège, Belgium
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
France
Bordeaux, France
Grenoble, France
Lyon, France
Nantes, France
Rennes, France
Hungary
Budapest, Hungary
Italy
Bologna, Italy
Lecco, Italy
Roma, Italy
Netherlands
Maastricht, Netherlands
United Kingdom
Belfast, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Southhampton, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Professor John Morgan, MA MD FRCP FESC Spire Southampton Hospital
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01277783     History of Changes
Other Study ID Numbers: ALSYNC
Study First Received: January 11, 2011
Last Updated: June 18, 2013
Health Authority: Canada: Health Canada
France: French Health Products Safety Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministero del Lavoro, della Salute e delle Politiche Sociali
Netherlands: Ministerie van Volksgezondheid, Welzijn en Sport
Belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Hungary: Office of Health Authorisation and Administrative Procedures

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014