MORE-CRT: More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01510652
• Collaborator: (none)
• Enrollment: 1,078
• Locations: 64
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 16.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Cardiac Complication; Heart Failure; Left Ventricular Cardiac Dysfunction; Inappropriate Phrenic Nerve Stimulation; Perioperative/Postoperative Complications	Procedure: BiP Group; Device: Quad Group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1078 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Quad Group Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet	Device: Quad Group; Implantation of quadripolar Left ventricular (LV) lead Quartet
Active Comparator: BiP Group Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)	Procedure: BiP Group; Implantation of standard Left Ventricular (LV) lead

Outcome Measures

Primary Outcome Measures

1. Lead Performance [6 months]

   Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.

Secondary Outcome Measures

1. Percentage of Cardiac Resynchronization Therapy Responders [Baseline and 6 months]

   Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)

2. Implant Duration [Total duration of the implant procedure reported at the end of the procedure]

   This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines

• Patients age is 18 years or greater

• Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form

• Patients must be willing and able to comply with all study requirements

Exclusion Criteria:

• Patients with a life expectancy <12 months.

• Patients who are or may potentially be pregnant.

• Patient has suffered any of the following in the 4 weeks prior to enrolment:

• Myocardial Infarction (MI)

• Coronary Artery Bypass Graft (CABG)

• Unstable Angina Pectoris

• Patient has primary valvular disease which has not been corrected

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Oost-Limburg	Genk		Belgium
2	Hopital La Citadelle	Liège		Belgium
3	Foothills Medical Center	Calgary		Canada
4	Royal Alexandra Hospital	Edmonton		Canada
5	QE II Health Sciences	Halifax		Canada
6	Institut de Cardiologie du Quebec - Hopital Laval	Quebec		Canada
7	HSC Heastern Health	St. Johns		Canada
8	Paijat-Hame Central Hospital	Lahti		Finland
9	Tampere University Hospital	Tampere		Finland
10	CHU La Cavale Blanche	Brest		France
11	CHU Gabriel Montpied	Clermont-Ferrand		France
12	CHRU Hopital Albert Michallon	Grenoble		France
13	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Lyon		France
14	Hopital de la Timone	Marseille		France
15	Hopital du Nord - CH Bourrely St. Antoine	Marseille		France
16	CHU Hopital G&R Laennec	Nantes		France
17	Nouvelles Cliniques Nantaises	Nantes		France
18	CHRU Hopital de Pontchaillou	Rennes		France
19	CHRU Hopital Charles Nicolle	Rouen		France
20	CHU St. Etienne	Saint Priest en Jarez		France
21	Clinique du Tonkin	Villeurbanne		France
22	Charite Campus Virchow Klinikum	Berlin		Germany
23	Unfallkrankenhaus Berlin-Marzahn	Berlin		Germany
24	Stadtische Kliniken Bielefeld	Bielefeld		Germany
25	Klinikum Coburg	Coburg		Germany
26	Elisabeth-Krankenhaus	Essen		Germany
27	Universitatsklinikum Greifswald	Greifswald		Germany
28	Universitatskliniken des Saarlandes	Homburg		Germany
29	Universitatsklinikum Leipzig	Leipzig		Germany
30	Klinikum Ludenscheid	Ludenscheid		Germany
31	Stadtisches Klinikum Ludwigshafen	Ludwigshafen		Germany
32	Krankenhaus der Barmherzigen	Trier		Germany
33	All India Institute of Medical Sciences	New Delhi		India
34	Escorts Heart Institute and Research Center	New Delhi		India
35	Barzilai Medical Center	Ashkelon		Israel
36	Soroka University Hospital	Beer Sheba		Israel
37	Kaplan Medical Center	Rehovot		Israel
38	Sheba Medical Center	Tel Hashomer		Israel
39	Policlinico S. Orsola & Malpighi	Bologna		Italy
40	Azienda Ospedaliera S.Anna e S.Sebastiano	Caserta		Italy
41	Azienda Ospedaliera Mater Domini	Catanzaro		Italy
42	Ospedale Vito Fazzi	Lecce		Italy
43	Ospedale Maggiore della Carità	Novara		Italy
44	Policlinico Casilino	Rome		Italy
45	Ospedale SS. Annunziata	Taranto		Italy
46	Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista	Torino		Italy
47	Ospedale Civile Maggiore Verona Borgo Trento	Verona		Italy
48	Amphia Hospital	Breda		Netherlands
49	Haga Ziekenhuis	Den Haag		Netherlands
50	MC Haaglanden	Den Haag		Netherlands
51	Medisch Spectrum Twente	Enschede		Netherlands
52	Slaskie Centrum Chorob Serca	Zabrze		Poland
53	Hospital de Basurto	Bilbao		Spain
54	Hospital Ramon y Cajal	Madrid		Spain
55	Hospital Universitari La Fe	Valencia		Spain
56	Basel University Hospital	Basel		Switzerland
57	Hopital Cantonal Universitaire de Geneva	Geneva		Switzerland
58	Fondazione Cardiocentro Ticino	Lugano		Switzerland
59	Universitaets Spital Zuerich	Zurich		Switzerland
60	Queen Elizabeth Hospital	Birmingham		United Kingdom
61	Royal Bournemouth Hospital	Bournemouth		United Kingdom
62	University Hospital of Wales	Cardiff		United Kingdom
63	St. Thomas Hospital	London		United Kingdom
64	James Cook University Hospital	Middlesbrough		United Kingdom

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Giuseppe Boriani, Pro., Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01510652
• Other Study ID Numbers: CR-11-006-HF-ID
• First Posted: Jan 16, 2012
• Last Update Posted: Feb 15, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Abbott Medical Devices: Cardiac Resynchronization therapy,; Heart Failure,; Left Ventricular Lead,; Quadripolar Left ventricular Lead,; Phrenic Nerve Stimulation,; Intra and post operative related complications
• Additional relevant MeSH terms: Heart Failure; Postoperative Complications

Study Results

Participant Flow

Pre-assignment Detail	1078 patients have been enrolled in this study, while 1074 have been randomized to Quad or BiP group. The randomization procedure happened after the enrollment and before the implant, this explains why not all 1078 patients have been randomized

Arm/Group Title	Quad Group	BiP Group
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet	Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead
Period Title: Overall Study
STARTED	719	355
Baseline	718	348
COMPLETED	627	288
NOT COMPLETED	92	67

Baseline Characteristics

Arm/Group Title	Quad Group	BiP Group	Total
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet	Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead	Total of all reporting groups
Overall Participants	718	348	1066
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.6 (10.2)	68.4 (9.7)	67.9 (10.1)
Sex: Female, Male (Count of Participants)
Female	173 24.1%	74 21.3%	247 23.2%
Male	545 75.9%	274 78.7%	819 76.8%
Left Ventricular Ejection Fraction (LVEF) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	27.1 (7.6)	27.5 (8.1)	27.2 (7.7)
Left Ventricular End-Diastolic Volume (LVEDV) (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	200.4 (74.9)	204.5 (72.0)	203.2 (80.6)
Left Ventricular End-Systolic Volume (LVESV) (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	151.2 (64.0)	149.0 (58.3)	150.5 (62.2)
QRS duration (ms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ms]	158 (29)	157 (27)	157.5 (28.4)
Cardiomyopathy (participants) [Number]
Ischemic	353 49.2%	196 56.3%	549 51.5%
Non Ischemic	365 50.8%	152 43.7%	517 48.5%
Atrial Arrhythmia History (participants) [Number]
Atrial Fibrillation	114 15.9%	58 16.7%	172 16.1%
Atrial Flutter	21 2.9%	7 2%	28 2.6%
None	583 81.2%	283 81.3%	866 81.2%

Outcome Measures

1. Primary Outcome

Title	Lead Performance
Description	Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quad Group	BiP Group
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet	Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead
Measure Participants	719	355
Number [% of patients with freedom from event]	83	74.4

2. Secondary Outcome

Title	Percentage of Cardiac Resynchronization Therapy Responders
Description	Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)

Arm/Group Title	Quad Group	BiP Group
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet	Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead
Measure Participants	476	218
Number [% of patients that are CRT responders]	62.0	56.0

3. Secondary Outcome

Title	Implant Duration
Description	This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.
Time Frame	Total duration of the implant procedure reported at the end of the procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is the number of patients with implant data duration time available.

Arm/Group Title	Quad Group	BiP Group
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet	Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead
Measure Participants	710	342
Mean (Standard Deviation) [min]	100.4 (54.5)	101.1 (51)

Adverse Events

Time Frame	6 Months: From the enrollment to 6 Months Follow Up
Arm/Group Title	Quad Group		BiP Group
Arm/Group Description	Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet		Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead
All Cause Mortality
	Quad Group		BiP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Quad Group		BiP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	332/719 (46.2%)		211/355 (59.4%)
Cardiac disorders
Arrhythmia	53/719 (7.4%)	55	35/355 (9.9%)	35
Heart Failure	41/719 (5.7%)	55	24/355 (6.8%)	30
Myocardial Infarction	4/719 (0.6%)	4	2/355 (0.6%)	2
Pericarditis	1/719 (0.1%)	1	1/355 (0.3%)	1
Other - Cardiac	20/719 (2.8%)	21	9/355 (2.5%)	9
Pericardial Effusion	2/719 (0.3%)	2	2/355 (0.6%)	2
General disorders
Other - Non Cardiac	81/719 (11.3%)	83	48/355 (13.5%)	51
Death for Unknown Causes	5/719 (0.7%)	5	3/355 (0.8%)	3
Infections and infestations
Infection	24/719 (3.3%)	24	22/355 (6.2%)	22
Injury, poisoning and procedural complications
Bleeding	1/719 (0.1%)	1	1/355 (0.3%)	1
Hematoma	16/719 (2.2%)	16	9/355 (2.5%)	9
Cardiac Perforation (RV Lead)	3/719 (0.4%)	3	2/355 (0.6%)	2
Cardiac Tamponade	1/719 (0.1%)	1	1/355 (0.3%)	1
Coronary Sinus Dissection (LV Lead related)	0/719 (0%)	0	1/355 (0.3%)	1
Coronary Sinus Dissection (Other Device related)	0/719 (0%)	0	2/355 (0.6%)	2
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/719 (0.3%)	2	5/355 (1.4%)	5
Phrenic Nerve Stimulation	1/719 (0.1%)	1	1/355 (0.3%)	1
Pneumothorax	7/719 (1%)	7	2/355 (0.6%)	2
Pulmonary Edema	5/719 (0.7%)	6	8/355 (2.3%)	8
Pulmonary Embolism	0/719 (0%)	0	1/355 (0.3%)	1
Skin and subcutaneous tissue disorders
Pocket Erosion	1/719 (0.1%)	1	1/355 (0.3%)	1
Surgical and medical procedures
Lead Dislodgement (LV Lead)	37/719 (5.1%)	37	20/355 (5.6%)	22
Lead Fracture (LV Lead)	0/719 (0%)	0	1/355 (0.3%)	1
Lead Dislodgement (RA Lead)	7/719 (1%)	9	5/355 (1.4%)	5
Lead Dislodgement (RV Lead)	15/719 (2.1%)	15	5/355 (1.4%)	5
Lead Fracture (RV Lead)	1/719 (0.1%)	2	0/355 (0%)	0
Lead Malfunction (RA Lead)	1/719 (0.1%)	1	0/355 (0%)	0
Lead Unstable Position (LV Lead)	1/719 (0.1%)	1	0/355 (0%)	0
Loss of Capture (RV Lead)	2/719 (0.3%)	2	0/355 (0%)	0
Other (Not Including Serious) Adverse Events
	Quad Group		BiP Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	186/719 (25.9%)		76/355 (21.4%)
Cardiac disorders
Arrhythmia	28/719 (3.9%)	29	8/355 (2.3%)	9
Heart Failure	8/719 (1.1%)	8	10/355 (2.8%)	10
Other - Cardiac	19/719 (2.6%)	24	12/355 (3.4%)	12
Pericardial Effusion	1/719 (0.1%)	1	0/355 (0%)	0
General disorders
Other - Non Cardiac	42/719 (5.8%)	43	16/355 (4.5%)	16
Infections and infestations
Infection	6/719 (0.8%)	6	2/355 (0.6%)	2
Injury, poisoning and procedural complications
Hematoma	25/719 (3.5%)	25	6/355 (1.7%)	8
Cardiac Perforation (Other Device Related)	1/719 (0.1%)	1	0/355 (0%)	0
Coronary Sinus Dissection (LV Lead Related)	1/719 (0.1%)	1	0/355 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	7/719 (1%)	7	4/355 (1.1%)	6
Phrenic Nerve stimulation	25/719 (3.5%)	26	11/355 (3.1%)	14
Pneumothorax	1/719 (0.1%)	1	1/355 (0.3%)	1
Pleural Effusion	1/719 (0.1%)	1	0/355 (0%)	0
Surgical and medical procedures
Lead Damaged during Implant	1/719 (0.1%)	1	0/355 (0%)	0
Lead Dislodgement (LV Lead)	7/719 (1%)	7	3/355 (0.8%)	3
Coronary Sinus Dissection (Other Device Related)	6/719 (0.8%)	6	2/355 (0.6%)	2
High Voltage Lead Impedance (RV Lead)	1/719 (0.1%)	1	0/355 (0%)	0
Lead Dislodgement (RA Lead)	1/719 (0.1%)	1	1/355 (0.3%)	1
Loss Of Capture (LV Lead)	1/719 (0.1%)	1	0/355 (0%)	0
Oversensing (RV Lead)	2/719 (0.3%)	2	0/355 (0%)	0
Pacing Impedance Out Of Range (LV Lead)	1/719 (0.1%)	1	0/355 (0%)	0
Pacing Impedance Out Of Range (RV Lead)	1/719 (0.1%)	1	0/355 (0%)	0

Limitations/Caveats

Patients were followed for only 6 months, studies with longer follow-up would add to the body of evidence.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.