SyncAV Post-Market Trial

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04100148

Collaborator

(none)

1,400

Enrollment

118

Locations

Arms

48.9

Anticipated Duration (Months)

11.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Device: SyncAV programmed ON Device: Fixed AV delay	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SyncAV Post-Market Trial

Actual Study Start Date :

Oct 3, 2019

Anticipated Primary Completion Date :

Apr 25, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SyncAV Arm Treatment Arm	Device: SyncAV programmed ON For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at 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.
Active Comparator: Fixed AV Delay Arm Control Arm	Device: Fixed AV delay 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.

Arm

Intervention/Treatment

Experimental: SyncAV Arm

Treatment Arm

Device: SyncAV programmed ON

For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at 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.

Active Comparator: Fixed AV Delay Arm

Control Arm

Device: Fixed AV delay

Outcome Measures

Primary Outcome Measures

Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months [12 months following trial randomization]
Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.

Secondary Outcome Measures

Percentage of CRT Responders at 12 months [12 months following trial randomization]
Percentage of subjects classified as CRT responders after 12 months of follow-up compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.
Reduction in LVESV in female subjects between baseline and 12 months [12 months following trial randomization]
Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
Percentage of female subjects classified as CRT Responders at 12 months [12 months following trial randomization]
Percentage of female subjects classified as CRT responders after 12 months of follow-up compared between female subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:
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
LVEF ≤ 35% based on a prior standard of care echocardiogram
Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,

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)

At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

Recent myocardial infarction or unstable angina within 40 days prior to signing consent
Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
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
Permanent or persistent AF at the time of signing consent
Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
Prior CRT device implant
Prior His Bundle pacing implant or plan to have His Bundle pacing implant
Pregnant or breastfeeding at the time of signing consent
Incapacitated or unable to read or write
Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
Life expectancy < 12 months due to any condition
Unavailable for at least 12 months of follow-up visits
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC.	Huntsville	Alabama	United States	35801
2	Arizona Cardiovascular Research Center	Phoenix	Arizona	United States	85016
3	HonorHealth	Scottsdale	Arizona	United States	85258
4	Comprehensive Cardiovascular	Bakersfield	California	United States	93309
5	Cardiovascular Consultants Heart Center	Fresno	California	United States	93720
6	Marin General Hospital	Greenbrae	California	United States	94904
7	USC University Hospital	Los Angeles	California	United States	90033-5313
8	Colorado Heart & Vascular, P.C.	Lakewood	Colorado	United States	80228
9	Washington Hospital Center	Washington	District of Columbia	United States	20010
10	Shands at the University of Florida	Gainesville	Florida	United States	32610
11	Heart Rhythm Solutions	Hollywood	Florida	United States	33328
12	Emory University Hospital	Atlanta	Georgia	United States	30322
13	Iowa Heart Center	West Des Moines	Iowa	United States	50266
14	Baptist Health Lexington	Lexington	Kentucky	United States	40503
15	Tufts Medical Center	Boston	Massachusetts	United States	02111
16	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
17	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
18	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
19	Catholic Medical Center	Manchester	New Hampshire	United States	03102
20	Deborah Heart & Lung Center	Browns Mills	New Jersey	United States	08015
21	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey	United States	08035
22	Lourdes Cardiology Services	Voorhees	New Jersey	United States	08043
23	New York Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
24	Mission Health & Hospitals	Asheville	North Carolina	United States	28801
25	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
26	Ohio State University	Columbus	Ohio	United States	43210
27	The Toledo Hospital	Toledo	Ohio	United States	43606
28	Hightower Clinical	Oklahoma City	Oklahoma	United States	73102
29	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
30	Medical University of South Carolina	Charleston	South Carolina	United States	29425
31	Texas Cardiac Arrhythmia	Austin	Texas	United States	78705
32	CHI St. Luke's Health Baylor College of Medicine Med. Ctr.	Houston	Texas	United States	77030
33	Memorial Katy Cardiology Associates	Houston	Texas	United States	77094
34	South Texas Cardiovascular Consultants	San Antonio	Texas	United States	78201
35	Heart Rhythm Associates	Shenandoah	Texas	United States	77380
36	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
37	Warringal Private Hospital	Heidelberg		Australia
38	Universitätsklinik Graz	Graz	Styria	Austria	8036
39	Hopital Erasme	Brussels		Belgium
40	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
41	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 2E8
42	Royal Jubilee Hospital	Victoria	British Columbia	Canada
43	Hopital du Sacre-Coeur de Montreal	Montréal	Montreal	Canada	H4J 1C5
44	HSC, Eastern Health	Saint John's	Newfoundland and Labrador	Canada	A1B 3V6
45	QE II Health Sciences	Halifax	Nova Scotia	Canada
46	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
47	St. Mary's General Hospital	Kitchener	Ontario	Canada
48	Cardiac Arrhythmia Research Group Inc. (CARGI)	Scarborough	Ontario	Canada	M1B 4Z8
49	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1WB
50	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec	Canada	H1T 1C8
51	McGill University Health Centre General Hospital	Montréal	Quebec	Canada
52	CHUS Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4
53	Royal Alexandra Hospital	Edmonton		Canada
54	CHUM	Montreal		Canada
55	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec		Canada	G1V 4G5
56	Tianjin Chest Hospital	Tianjin	Heping	China	300041
57	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
58	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310016
59	APEX Foundation	Medellin	Antioq	Colombia
60	Helsinki University Central Hospital (HYKS)	Helsinki		Finland
61	Centre de Cardiologie du Pays Basque	Bayonne	AQT	France
62	Hopital Henri Mondor	Creteil	Ile-de-France	France	94010
63	CHR de La Reunion - Site du CHFG	Saint-Denis Cedex	Ile-de-France	France	97405
64	CHU Rangueil Toulouse	Toulouse	Midi-Pyrenees	France	31059
65	CHRU Hopital de Pontchaillou	Rennes		France
66	St-Etienne CHU	Saint-Priest-En-Jarez		France
67	Klinikum der Ruprecht-Karls-Universität Heidelberg	Heidelberg	Bad-wur	Germany
68	Herzzentrum Dresden GmbH Universitätsklinik	Dresden	Saxony	Germany
69	Kerckhoff-Klinik gGmbH	Bad Nauheim		Germany
70	Medizinische Hochschule Hannover	Hannover		Germany
71	The University of Hong Kong (Queen Mary Hospital)	Hong Kong		Hong Kong
72	Asian Institute of Gastroenterology (AIG) Hospital	Hyderabad	Andprad	India	500082
73	Care Institute of Medical Sciences	Ahmedabad	Gujarat	India	380060
74	Apollo Hospitals, Bangalore	Bangalore	Karnataka	India	560076
75	Narayana Institute of Cardiac Sciences, Bommasandra	Bangalore	Karnataka	India	560099
76	Medanta - The Medicity Hospital	Gurgaon		India
77	Max Super Specialty Hospital	New Delhi		India
78	Mater Dei Hospital	Bari	Apulia	Italy	70125
79	Azienda Ospedaliera Di Venere	Carbonara	Apulia	Italy	70131
80	Azienda Ospedaliera Universitaria MaterDomini	Catanzaro	Calabria	Italy	88100
81	Azienda Ospedaliera S. G. Moscati	Avellino		Italy
82	Chiba University	Chiba-shi	Chiba	Japan
83	Hyogo College of Medicine	Nishinomiya	Hyogo	Japan	663-8501
84	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa-Ken	Japan	216-8511
85	Kitasato University Hospital	Sagamihara	Kanagwa	Japan	252-0375
86	Sejong Hospital	Bucheon	Sudogwn	Korea, Republic of
87	Keimyung University Dongsan Medical Center	Daegu	Sudogwn	Korea, Republic of	42601
88	Seoul National University Bundang Hospital	Seongnam	Sudogwn	Korea, Republic of	463-707
89	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
90	Asan Medical Centre	Seoul		Korea, Republic of
91	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of
92	Amsterdam Academic Medical Centre (AMC)	Amsterdam	Noord-h	Netherlands	1105 AZ
93	Scanmed SA	Krakow	Lesrpld	Poland
94	Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu	Poznań		Poland
95	Hospital distrital de Santarém, E.P.E.	Santarém	Sntarem	Portugal
96	Santa Maria Hospital	Lisboa		Portugal
97	Arrhythmia Group LLC	Ponce		Puerto Rico
98	Meshalkin National Medical Research Center	Novosibirsk	Siberia	Russian Federation
99	King Fahad Armed Forces Hospital	Jeddah	Makkah	Saudi Arabia
100	King Faisal Specialist Hospital (KFSH)	Riyadh	Riyadh Province	Saudi Arabia	12713
101	King Fahad Medical City	Riyadh		Saudi Arabia
102	King Khalid University Hospital	Riyadh		Saudi Arabia
103	Clinical Center of Serbia - Pacemaker Center	Belgrade		Serbia
104	National Heart Centre Singapore	Singapore	Central	Singapore
105	Hospital Universitario Infanta Cristina	Badajoz		Spain
106	Hospital Clínic de Barcelona	Barcelona		Spain
107	Fundación Jiménez Díaz	Madrid		Spain
108	Hospital Puerta de Hierro - Hospital Universitario	Madrid		Spain
109	HCU Virgen de la Victoria	Málaga		Spain
110	Hospital Universitario de Salamanca	Salamanca		Spain
111	Karolinska University Hospital, Solna	Stockholm		Sweden
112	Basel University Hospital	Basel		Switzerland
113	Taichung Veterans General Hospital	Taichung		Taiwan
114	Phramongkutklao Hospital	Bangkok	Central Thailand	Thailand	10400
115	Cleveland Clinic Abu Dhabi	Abu Dhabi		United Arab Emirates
116	Southampton University Hospital	Southampton	Soeast	United Kingdom	SO16 6YD
117	John Radcliffe Hospital	Oxford	South East England	United Kingdom	OX3 9DU
118	The Royal Sussex County Hospital	Brighton		United Kingdom