CROSS X4: Quadripolar CRT-D On Currently Approved Lead SystemS

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02232984
• Collaborator: (none)
• Enrollment: 749
• Locations: 60
• Actual Duration (Months): 24
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate different ways to program around extracardiac stimulation.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure

Study Design

• Study Type: Observational
• Actual Enrollment: 749 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Quadripolar CRT-D On Currently Approved Lead SystemS
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
All study patients All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance.

Outcome Measures

Primary Outcome Measures

1. Number of Vectors With Phrenic Nerve Stimulation (PNS) [Pre-discharge (up to 7 days post implant)]

   The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.

Secondary Outcome Measures

1. Final Pacing Treshold at Pre-discharge [Pre-discharge (up to 7 days post implant)]

   Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.

2. Final LV Lead Impedance at Pre-discharge [Pre-discharge (up to 7 days post implant)]

   Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.

3. Final Sensing Amplitude at Pre-discharge [Pre-discharge (up to 7 days post implant)]

   Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.

4. Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems [At time of implantation (0 to 30 days post consent signature)]

   Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead

• Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol

• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

• Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

• Subject is enrolled in any other concurrent study, without prior approval from BSC

• Women of childbearing potential who are or might be pregnant at the time of study enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Gilbert Medical Center	Gilbert	Arizona	United States	85297
2	Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona	Phoenix	Arizona	United States	85006
3	St. Joseph's Hospital	Phoenix	Arizona	United States	85013
4	Yuma Regional Medical Center	Yuma	Arizona	United States	85364
5	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas	United States	72401
6	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas	United States	72114
7	Comprehensive Cardiovascular Medical Group	Bakersfield	California	United States	93309
8	Cardiac Device Rhythm Specialists, Inc	Los Angeles	California	United States	90033
9	Desert Heart Rhythm	Palm Springs	California	United States	92262
10	Bradenton Cardiology Center	Bradenton	Florida	United States	34205
11	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
12	North Florida VA	Gainesville	Florida	United States	32610
13	Northeast Cardiology Clinic	Jacksonville	Florida	United States	32216
14	Watson Center Clinic for Research	Lakeland	Florida	United States	33805
15	Charlotte Heart	Port Charlotte	Florida	United States	33952
16	Brevard Cardiovascular Res. Associates	Rockledge	Florida	United States	32955
17	Northside Hospital	Saint Petersburg	Florida	United States	33709
18	Central Florida Regional	Sanford	Florida	United States	32771
19	Sarasota Memorial Hosptial	Sarasota	Florida	United States	34239
20	Tallahassee Memorial	Tallahassee	Florida	United States	32308
21	Emory University	Atlanta	Georgia	United States	30322
22	Atlanta Heart Specialist	Atlanta	Georgia	United States	30342
23	AnMed Health	Augusta	Georgia	United States	29621
24	University Hospital	Augusta	Georgia	United States	30901
25	North Georgia Heart Foundation	Gainesville	Georgia	United States	30501
26	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
27	West Suburban Hospital	Oak Park	Illinois	United States	60302
28	Central DuPage Medical Center	Winfield	Illinois	United States	60190
29	Lutheran Hospital	Fort Wayne	Indiana	United States	46804
30	Parkview Hospital	Fort Wayne	Indiana	United States	46843
31	Community Hospital	Munster	Indiana	United States	46321
32	Baptist Health Lexington	Lexington	Kentucky	United States	40503
33	Ark-La-Tex Cardiology, APMC	Shreveport	Louisiana	United States	71103
34	Willis Knighton	Shreveport	Louisiana	United States	71105
35	University of Michigan	Ann Arbor	Michigan	United States	48109
36	St. John Hospital and Medical Center	Detroit	Michigan	United States	48236
37	Hurley Hospital	Flint	Michigan	United States	48532
38	Genesys Medical Center	Grand Blanc	Michigan	United States	48439
39	Allegiance Health	Jackson	Michigan	United States	49201
40	Lakeland Medical Center	Saint Joseph	Michigan	United States	49085
41	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
42	Desert Springs	Las Vegas	Nevada	United States	89169
43	Catholic Medical Center	Manchester	New Hampshire	United States	03102
44	Atlanticare Regional Medical Center	Atlantic City	New Jersey	United States	08401
45	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
46	Mercy Hospital/ Buffalo Heart Group	Buffalo	New York	United States	14215
47	Genesis Health System	Zanesville	Ohio	United States	43701
48	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
49	Mercer Bucks Cardiology	Newtown	Pennsylvania	United States	18940
50	Regional Hospital of Scranton	Scranton	Pennsylvania	United States	18510
51	Core CV Research	Jackson	Tennessee	United States	38305
52	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
53	Houston Arrhythmia Associates	Houston	Texas	United States	77024
54	Houston Cardiovascular Associates	Houston	Texas	United States	77030
55	Heart Institute of East Texas	Lufkin	Texas	United States	75904
56	Woodlands North Houston Heart Ctr	The Woodlands	Texas	United States	17350
57	The University of Vermont Medical Center	Burlington	Vermont	United States	05401
58	Hunter Holmes VA Medical Center	Richmond	Virginia	United States	23249
59	Virginia Mason Medical Center	Seattle	Washington	United States	98101
60	Belin Healthcare	Green Bay	Wisconsin	United States	54301

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Christopher R Ellis, MD, Vanderbilt University Medical Center, Nashville, TN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02232984
• Other Study ID Numbers: CROSSX4
• First Posted: Sep 8, 2014
• Last Update Posted: Apr 9, 2019
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Boston Scientific Corporation: Heart Failure; Cardiac Resynchronization Therapy (CRT); CRT-D; Quadripolar pacing
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Pre-assignment Detail	A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
Period Title: Overall Study
STARTED	749
Successfully Implanted	675
COMPLETED	672
NOT COMPLETED	77

Baseline Characteristics

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
Overall Participants	742
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.2 (10.3)
Sex: Female, Male (Count of Participants)
Female	180 24.3%
Male	562 75.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	742 100%
Left Ventricular Ejection Fraction (LVEF) % (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	26.5 (8.3)
QRS width (ms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ms]	153.7 (28.6)

Outcome Measures

1. Primary Outcome

Title	Number of Vectors With Phrenic Nerve Stimulation (PNS)
Description	The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
Time Frame	Pre-discharge (up to 7 days post implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
Measure Participants	672
Unique pacing vectors with PNS	181
Common vectors with PNS	189

2. Secondary Outcome

Title	Final Pacing Treshold at Pre-discharge
Description	Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time Frame	Pre-discharge (up to 7 days post implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.
Measure Participants	672
Mean (Standard Deviation) [Volts]	1.93 (1.87)

3. Secondary Outcome

Title	Final LV Lead Impedance at Pre-discharge
Description	Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time Frame	Pre-discharge (up to 7 days post implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
Measure Participants	672
Mean (Standard Deviation) [Ohms]	1034.7 (310.6)

4. Secondary Outcome

Title	Final Sensing Amplitude at Pre-discharge
Description	Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
Time Frame	Pre-discharge (up to 7 days post implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
Measure Participants	672
Mean (Standard Deviation) [Milivolts]	13.30 (6.40)

5. Secondary Outcome

Title	Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
Description	Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.
Time Frame	At time of implantation (0 to 30 days post consent signature)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acuity Pro LV Lead Delivery System	Other LV Lead Delivery Systems
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.
Measure Participants	394	281
Skin to skin time (min)	82.4 (38.9)	87.8 (38.9)
Lead placement time (min)	24.5 (23.5)	29.8 (24.8)
CS Canulation Time (min)	6.2 (9.4)	7.8 (12.2)
Overall catheter in the body time (min)	25.9 (21.8)	32.7 (25.1)

Adverse Events

Time Frame	From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.
Arm/Group Title	All Study Patients
Arm/Group Description	All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance.
All Cause Mortality
	All Study Patients
	Affected / at Risk (%)	# Events
Total	1/749 (0.1%)
Serious Adverse Events
	All Study Patients
	Affected / at Risk (%)	# Events
Total	16/749 (2.1%)
Cardiac disorders
Inadvertent VT/VF	2/749 (0.3%)	2
Dislodgement - undersensing RV	1/749 (0.1%)	1
Dislodgement - no reported signs - RA	4/749 (0.5%)	4
Elevated threshold - RV	1/749 (0.1%)	1
Dislodgment - no reported signs - LV	3/749 (0.4%)	3
Dislodgment - no reported signs - RV	1/749 (0.1%)	1
Injury, poisoning and procedural complications
Adverse reaction - general	1/749 (0.1%)	1
Adverse drug reaction - respiratory	1/749 (0.1%)	1
Hematoma pocket <= 30 days	1/749 (0.1%)	1
Coronary venous dissection	1/749 (0.1%)	1
Other (Not Including Serious) Adverse Events
	All Study Patients
	Affected / at Risk (%)	# Events
Total	11/749 (1.5%)
Cardiac disorders
Dislodgement - no reported signs - RA	5/749 (0.7%)	5
Injury, poisoning and procedural complications
Coronary Venous dissection	6/749 (0.8%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.