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
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|
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 (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ALternate Site Cardiac ReSYNChronization Study|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||October 2014|
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.
- 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.
- Implant Success [ Time Frame: Implant ]Number of participants with a successful implant of Model 3830 lead.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
|Principal Investigator:||Professor John Morgan, MD||Spire Southampton Hospital|