Clinical trial NCT01277783: ALternate Site Cardiac ReSYNChronization (ALSYNC) Study
Official title: ALternate Site Cardiac ReSYNChronization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients Free From Lead, Delivery System and Implant Related Complications.
timeFrame: 6 months
Secondary outcomes:
measure: Implant Success
timeFrame: Implant
measure: Number of Questionnaires Reporting None of the Handling and Implant Characteristics as Poor
timeFrame: Implant
measure: Bipolar Sensing Amplitude of the Model 3830 Lead in the LV at 12 Months
timeFrame: 12 months
measure: Bipolar Pacing Threshold of the Model 3830 Lead in the LV at 12 Months
timeFrame: 12 months
measure: Bipolar Pacing Impedance of the Model 3830 Lead in the LV at 12 Months
timeFrame: 12 months
measure: Subjects With 1 Class of NYHA Improvement From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Distance Walked at 6 Minute Hall Walk at the 12 Month Visit
timeFrame: 12 months
measure: Percent Change in Left Ventricular Ejection Fraction From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Milliliters Change in Left Ventricular End-Systolic Volume at 6 Months
timeFrame: 6 months
measure: Millimeters Change in Left Ventricular End-Diastolic Diameter From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Number of Subjects With Mitral Regurgitation Improvement of at Least One Class From Baseline to 6 Months
timeFrame: baseline and 6 months
measure: Change in (NT-pro)BNP Levels From Baseline to 6 Months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan - Campus Sint-Jan
city: Liège
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - University Campus
state: Ontario
city: Bordeaux
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Grenoble
country: France
facility: CHU Grenoble Hôpital Michalon
city: Lyon
country: France
facility: Infirmerie Protestante de Lyon
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU de Rennes
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi
city: Lecco
country: Italy
facility: Presidio Ospedaliero Alessandro Manzoni
city: Roma
country: Italy
facility: Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht (AZM)
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - The Heart Hospital
city: Southhampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Spire Southampton Hospital
name: Professor John Morgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.