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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
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.
AZ Sint-Jan - Campus Sint-Jan
Bruges, Belgium
Centre Hospitalier Regional de la Citadelle
Liège, Belgium
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.
Time frame: 6 months
Implant Success
Number of participants with a successful implant of Model 3830 lead.
Time frame: Implant
Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor
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.
Time frame: Implant
Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months
Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.
Time frame: 12 months
Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months
Bipolar measurement of Model 3830 lead voltage threshold at 0.4ms pulse width using the implanted device at the 12 month visit
Time frame: 12 months
Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months
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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
...and 8 more locations
Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit
Time frame: 12 months
Subjects With 1 Class of NYHA Improvement From Baseline to 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
Time frame: baseline and 6 months
Distance Walked at 6 Minute Hall Walk at the 12 Month Visit
Distance walked at the 6 minute hall walk test at the 12 month visit
Time frame: 12 months
Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months
Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months
Time frame: baseline and 6 months
Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months
Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months
Time frame: 6 months
Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months
Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months
Time frame: baseline and 6 months
Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months
Reported is the number of patients with at least one class improvement from baseline to 6 months
Time frame: baseline and 6 months
Change in (NT-pro)BNP Levels From Baseline to 6 Months
Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months
Time frame: baseline and 6 months