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ALternate Site Cardiac ReSYNChronization (ALSYNC) Study (ALSYNC)

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ClinicalTrials.gov Identifier: NCT01277783
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Endocardial Left Ventricular pacing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ALternate Site Cardiac ReSYNChronization Study
Study Start Date : March 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Implant Success [ Time Frame: Implant ]
    Number of participants with a successful implant of Model 3830 lead.

  2. Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor [ Time Frame: Implant ]
    Questionaires were collected for each LV lead implant attempt, reattempt, and LV lead modification. To evaluate the ease of positioning of the Model 3830 lead and the Models 6227ATS and 6248HS, JS, JL catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent was used for each of the ten questions on the questionnaire. Outcome reports the number of questionnaires where no single question was answered with Poor.

  3. Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months [ Time Frame: 12 months ]
    Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.

  4. Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months [ Time Frame: 12 months ]
    Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit

  5. Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months [ Time Frame: 12 months ]
    Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit

  6. Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    NYHA Class change was evaluated between baseline and the 6 months visit. Reported are the subjects with at least 1 class improvement from baseline to 6 months

  7. Distance Walked at 6 Minute Hall Walk at the 12 Month Visit [ Time Frame: 12 months ]
    Distance walked at the 6 minute hall walk test at the 12 month visit

  8. Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months

  9. Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months [ Time Frame: 6 months ]
    Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months

  10. Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months

  11. Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    Reported is the number of patients with at least one class improvement from baseline to 6 months

  12. Change in (NT-pro)BNP Levels From Baseline to 6 Months [ Time Frame: baseline and 6 months ]
    Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (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
  • Patients with exclusion criteria required by local law

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277783


Locations
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Belgium
AZ Sint-Jan - Campus Sint-Jan
Brugge, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, Belgium
Canada, British Columbia
Saint Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
London Health Sciences Centre - University Campus
London, Ontario, Canada
France
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
Hungary
Semmelweis Egyetem AOK
Budapest, Hungary
Italy
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
Netherlands
Academisch Ziekenhuis Maastricht (AZM)
Maastricht, Netherlands
United Kingdom
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
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Professor John Morgan, MD Spire Southampton Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01277783     History of Changes
Other Study ID Numbers: ALSYNC
First Posted: January 17, 2011    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases