N/A
N=138
ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01277783 ↗Enrolled (actual)
138
Serious AEs
65.1%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. — 82.2 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endocardial Left Ventricular pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Free From Lead, Delivery System and Implant Related Complications. |
82.2 | — |
| SECONDARY Implant Success |
118 | — |
| SECONDARY Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor |
75 | — |
| SECONDARY Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months |
11 | — |
| SECONDARY Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months |
0.84 | — |
| SECONDARY Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months |
596 | — |
| SECONDARY Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months |
62 | — |
| SECONDARY Distance Walked at 6 Minute Hall Walk at the 12 Month Visit |
391 | — |
| SECONDARY Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months |
36.1 | — |
| SECONDARY Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months |
121 | — |
| SECONDARY Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months |
63.7 | — |
| SECONDARY Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months |
33 | — |
| SECONDARY Change in (NT-pro)BNP Levels From Baseline to 6 Months |
444; 2554 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01277783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.