Clinical trial NCT04100148: SyncAV Post-Market Trial
Official title: SyncAV Post-Market Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congestive Heart Failure
Keywords: SyncAV feature
CRT optimization
CRT non-responders
ECG optimization
Cardiac remodeling
CRT with SyncAV
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-09-24
Enrollment: 1686
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

Detailed description: The SyncAV Post-Market Trial is designed as a prospective, randomized, multi-center trial. The trial will require physicians to implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads. Sites will randomize subjects in a 1:1 ratio within 2 - 6 weeks post successful CRT implant: Arm 1 - SyncAV CRT programmed ON; Arm 2 - programmed fixed atrioventricular (AV) delay.

For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at biventricular (BiV) pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.

For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.

Sites will collect data at baseline (before CRT implant), randomization, and at 3-month, 6-month, and 12-month visits. For subjects randomized to the SyncAV ON arm, sites will optimize the SyncAV feature again at 3 months and 6 months in the same manner as the randomization visit.

Eligibility criteria: Inclusion Criteria:

1. Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria:

   1. Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist
   2. LVEF ≤ 35% based on a prior standard of care echocardiogram
   3. Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,

   i. QRS duration ≥ 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval ≤ 280 ms on surface ECG)
2. At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

1. Recent myocardial infarction or unstable angina within 40 days prior to signing consent
2. Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
3. Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
4. Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent
5. Permanent or persistent AF at the time of signing consent
6. Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
7. Prior CRT device implant
8. Prior His Bundle pacing implant or plan to have His Bundle pacing implant
9. Pregnant or breastfeeding at the time of signing consent
10. Incapacitated or unable to read or write
11. Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
12. Life expectancy \< 12 months due to any condition
13. Unavailable for at least 12 months of follow-up visits
14. Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott

Primary outcomes:
measure: Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
timeFrame: 12 months following trial randomization
Secondary outcomes:
measure: Percentage of CRT Responders at 12 months
timeFrame: 12 months following trial randomization
measure: Reduction in LVESV in female subjects between baseline and 12 months
timeFrame: 12 months following trial randomization
measure: Percentage of female subjects classified as CRT Responders at 12 months
timeFrame: 12 months following trial randomization
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular
state: California
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Lakewood
country: United States
facility: Colorado Heart & Vascular, P.C.
state: Colorado
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Hollywood
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Brown Mills
country: United States
facility: Deborah Heart & Lung Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Voorhees Township
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
state: Texas
city: Houston
country: United States
facility: Memorial Katy Cardiology Associates
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Shenandoah
country: United States
facility: Heart Rhythm Associates
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Graz
country: Austria
facility: Universitätsklinik Graz
state: Styria
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Montréal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Montreal
city: Saint John's
country: Canada
facility: HSC, Eastern Health
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QE II Health Sciences
state: Nova Scotia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Cardiac Arrhythmia Research Group Inc. (CARGI)
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Fleurimont
state: Quebec
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Montreal
country: Canada
facility: CHUM
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hôpital Laval)
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Heping
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital (HYKS)
city: Creteil
country: France
facility: Hopital Henri Mondor
state: Ile-de-France
city: Saint-Denis Cedex
country: France
facility: CHR de La Reunion - Site du CHFG
state: Ile-de-France
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
state: Midi-Pyrenees
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Saint-Priest-En-Jarez
country: France
facility: St-Etienne CHU
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karls-Universität Heidelberg
state: Bad-wur
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
state: Saxony
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong (Queen Mary Hospital)
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology (AIG) Hospital
state: Andprad
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences
state: Gujarat
city: Bangalore
country: India
facility: Apollo Hospitals, Bangalore
state: Karnataka
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Sciences, Bommasandra
state: Karnataka
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
city: New Delhi
country: India
facility: Max Super Specialty Hospital
city: Bari
country: Italy
facility: Mater Dei Hospital
state: Apulia
city: Carbonara
country: Italy
facility: Azienda Ospedaliera Di Venere
state: Apulia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria MaterDomini
state: Calabria
city: Avellino
country: Italy
facility: Azienda Ospedaliera S. G. Moscati
city: Chiba-shi
country: Japan
facility: Chiba University
state: Chiba
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa-Ken
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagwa
city: Bucheon
country: Korea, Republic of
facility: Sejong Hospital
state: Sudogwn
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Sudogwn
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Sudogwn
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Centre
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Amsterdam
country: Netherlands
facility: Amsterdam Academic Medical Centre (AMC)
state: Noord-h
city: Krakow
country: Poland
facility: Scanmed SA
state: Lesrpld
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
city: Ponce
country: Puerto Rico
facility: Arrhythmia Group LLC
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Medical Research Center
state: Siberia
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces Hospital
state: Makkah
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital (KFSH)
state: Riyadh Province
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia - Pacemaker Center
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro - Hospital Universitario
city: Málaga
country: Spain
facility: HCU Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
state: Central Thailand
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
state: Soeast
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: South East England
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Niraj Varma, MD
role: PRINCIPAL_INVESTIGATOR
References: