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ALternate Site Cardiac ReSYNChronization (ALSYNC) Study (ALSYNC)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endocardial Left Ventricular pacing
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Sint-Jan - Campus Sint-Jan
  • Centre Hospitalier Regional de la Citadelle
  • Saint Paul's Hospital
  • London Health Sciences Centre - University Campus
  • Hôpital Haut-Lévêque - CHU de Bordeaux
  • CHU Grenoble Hôpital Michalon
  • Infirmerie Protestante de Lyon
  • Nouvelles Cliniques Nantaises
  • Hôpital Pontchaillou - CHU de Rennes
  • Semmelweis Egyetem AOK
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi
  • Presidio Ospedaliero Alessandro Manzoni
  • Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri
  • Academisch Ziekenhuis Maastricht (AZM)
  • Royal Victoria Hospital
  • Golden Jubilee National Hospital
  • University College London Hospitals NHS Foundation Trust - The Heart Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endocardial Left Ventricular pacing

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Implant Success
Number of participants with a successful implant of Model 3830 lead.
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.
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.
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
Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 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
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
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
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
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
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
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
Change in either Brain Natriuretic Peptide (BNP) or N-Terminal-prohormone BNP (NT-proBNP) levels from baseline to 6 months

Full Information

First Posted
January 11, 2011
Last Updated
March 20, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01277783
Brief Title
ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
Acronym
ALSYNC
Official Title
ALternate Site Cardiac ReSYNChronization Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocardial Left Ventricular pacing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endocardial Left Ventricular pacing
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.
Description
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
Secondary Outcome Measure Information:
Title
Implant Success
Description
Number of participants with a successful implant of Model 3830 lead.
Time Frame
Implant
Title
Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor
Description
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
Title
Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months
Description
Sensing amplitude measurement was taken with the implanted device at the 12 month follow-up visit.
Time Frame
12 months
Title
Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months
Description
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
Title
Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months
Description
Measurement of Impedance of the Model 3830 Lead in the LV using the implanted device at the 12 month visit
Time Frame
12 months
Title
Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months
Description
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
Title
Distance Walked at 6 Minute Hall Walk at the 12 Month Visit
Description
Distance walked at the 6 minute hall walk test at the 12 month visit
Time Frame
12 months
Title
Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months
Description
Percent change in Left Ventricular Ejection Fraction (LVEF) was measured from baseline to 6 months
Time Frame
baseline and 6 months
Title
Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months
Description
Milliliters change in Left Ventricular End-Systolic Volume (LVESV) from baseline to 6 months
Time Frame
6 months
Title
Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months
Description
Millimeters change in Left Ventricular End-Diastolic Diameter (LVEDD) from baseline to 6 months
Time Frame
baseline and 6 months
Title
Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months
Description
Reported is the number of patients with at least one class improvement from baseline to 6 months
Time Frame
baseline and 6 months
Title
Change in (NT-pro)BNP Levels From Baseline to 6 Months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor John Morgan, MD
Organizational Affiliation
Spire Southampton Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan - Campus Sint-Jan
City
Brugge
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liège
Country
Belgium
Facility Name
Saint Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
London Health Sciences Centre - University Campus
City
London
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Haut-Lévêque - CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Grenoble Hôpital Michalon
City
Grenoble
Country
France
Facility Name
Infirmerie Protestante de Lyon
City
Lyon
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
Hôpital Pontchaillou - CHU de Rennes
City
Rennes
Country
France
Facility Name
Semmelweis Egyetem AOK
City
Budapest
Country
Hungary
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Presidio Ospedaliero Alessandro Manzoni
City
Lecco
Country
Italy
Facility Name
Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri
City
Roma
Country
Italy
Facility Name
Academisch Ziekenhuis Maastricht (AZM)
City
Maastricht
Country
Netherlands
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - The Heart Hospital
City
London
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southhampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29579617
Citation
Biffi M, Defaye P, Jais P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.
Results Reference
derived
PubMed Identifier
26787437
Citation
Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.
Results Reference
derived

Learn more about this trial

ALternate Site Cardiac ReSYNChronization (ALSYNC) Study

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