ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01277783
First received: January 11, 2011
Last updated: June 18, 2013
Last verified: June 2013

January 11, 2011
June 18, 2013
January 2011
April 2014   (final data collection date for primary outcome measure)
Percentage of patients free from lead, delivery system and implant related complications. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Percentage of patients free from lead, delivery system and implant related complications [ Time Frame: Six months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277783 on ClinicalTrials.gov Archive Site
  • Percentage of patients with successful lead implant in the Left Ventricle via a superior approach. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Ease of positioning the SelectSecure® Model 3830 using the Models 6227ATS, 6248HS, JS, or JL catheters. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    To evaluate the ease of positioning of the above lead and catheters, a rating scale of Poor, Fair, Good, Very good, and Excellent will be used.
  • Left Ventricular pacing voltage threshold at 0.4 ms pulse width. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Left Ventricular sensed R-wave amplitude. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Left Ventricular pacing impedance. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in NYHA Class. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in 6 minute hallwalk. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End-Systolic Volume. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular Ejection Fraction. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End-Diastolic Diameter. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Mitral Regurgitation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Brain Natriuretic Peptide (BNP)/N-Terminal-prohormone BNP levels. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with successful lead implant in the Left Ventricle via a superior approach. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Ease of positioning the SelectSecure® Model 3830 using the Models 6227ATS,6248HS,JS, or JL catheters. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Chracterize Left Ventricular pacing voltage threshold at 0.4 ms pulse width using descriptive statistics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Chracterize Left Ventricular sensed R-wave amplitude using descriptive statistics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Characterize Left Ventricular pacing impedance using descriptive statistics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in NYHA Class [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in 6 minute hallwalk [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End-Systolic Volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
ALternate Site Cardiac ReSYNChronization 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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Device: Medtronic Model 6227ATS deflectable delivery catheter
    Endocardial Left Ventricular pacing lead delivery
  • Device: Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter
    Endocardial Left Ventricular pacing lead delivery
  • Device: Medtronic Model 3830
    Endocardial Left Ventricular pacing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
130
December 2014
April 2014   (final data collection date for primary outcome measure)

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 (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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Belgium,   Canada,   United Kingdom,   Hungary,   Italy,   Netherlands
 
NCT01277783
ALSYNC
Yes
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Professor John Morgan, MA MD FRCP FESC Spire Southampton Hospital
Medtronic Cardiac Rhythm Disease Management
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP