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NCT Number: NCT01277783

ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan - Campus Sint-Jan, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

ALternate Site Cardiac ReSYNChronization Study

Acronym: ALSYNC

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2011
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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