REPLACE: Implantable Cardiac Pulse Generator Replacement Registry

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00395447
• Collaborator: (none)
• Enrollment: 1,744
• Locations: 71
• Duration (Months): 23
• Patients Per Site: 24.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.

Condition or Disease	Intervention/Treatment	Phase
Device Replacement; Elective Replacement (ERI); Device Advisory; Device Upgrade; Postoperative Complications	Procedure: Straight-forward Device Replacement; Procedure: Device Replacement with Upgrade

Detailed Description

Device replacements occur for many reasons, including elective replacement indication (ERI), manufacturer advisory, and upgrade.

Recently pacemaker and implantable cardioverter (ICD) advisories have created a dilemma for both physicians and patients. While the risk of device malfunction is low, replacement rates following an advisory are usually high and complication rates following device replacement are not widely known. One retrospective analysis of ICD advisories in Canada reported an 18.3% replacement rate, and subsequent 8.1% complication rate directly related to the replacement.

Device replacements also occur in order to upgrade an existing system. Clinical studies have shown that cardiac resynchronization therapy (CRT) significantly reduces all-cause mortality and hospitalization in patients with advanced heart failure (HF). As a result of expanding indications for this therapy, many standard ICD patients are being upgraded to CRT-D systems. Complication rates related to upgrades of these systems are also not widely known.

To our knowledge, the risk of complications following a device replacement has not been studied prospectively in any patient population. Limited data are available to guide physicians when weighing the risks and benefits of device replacement.

This is a prospective multi-center study. 1750 patients at 100 clinical sites will be enrolled prior to generator replacement. Patients will be implanted and followed for 6 months to assess any complications related to the replacement procedure.

Patients with any legally marketed device for explant can be enrolled. The replacement device can be from any manufacturer.

Study Design

• Study Type: Observational
• Actual Enrollment: 1744 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Assessment of the Complication Rate After Device Replacement Due to ERI, Advisory or Upgrade
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Straight-forward Device Replacement Subject with a straight-forward device replacement without lead revisions or additions.	Procedure: Straight-forward Device Replacement
Device Replacement with Upgrade Subjects with a device replacement and planned lead upgrade, revision, or addition.	Procedure: Device Replacement with Upgrade

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification) [6 months]

   The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Is able to give informed consent

• Is identified for generator replacement without system modification or generator replacement including planned system modification, regardless of generator manufacturer

• Is clinically stable to tolerate the surgical procedure

• Age 18 years or greater

• Is geographically stable and able to return to the investigational site for follow-up care through the six-month visit

Exclusion Criteria:

• Inability or unwillingness to give informed consent

• Current system infection requiring generator explantation or lead extraction

• Generator replacement requiring planned lead extraction

• Participating in another cardiovascular investigational drug or device registry

• A life expectancy of less than six months

• Expected to receive a heart transplant within 6 months

• All vulnerable subjects as defined by the FDA Office of Human Research Protection or the local IRB providing oversight

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Mesa Cardiovascular	Mesa	Arizona	United States	85206
3	Stanislaus Cardiology	Modesto	California	United States	95355
4	Desert Cardiology	Rancho Mirage	California	United States	92270
5	Mercy General Hospital	Sacramento	California	United States	95819
6	UCSD Medical Center	San Diego	California	United States	92103
7	UCSF	San Francisco	California	United States	94143
8	Penrose Hospital	Colorado Springs	Colorado	United States	80907
9	Aurora Denver Cardiology	Denver	Colorado	United States	80012
10	George Washington University	Washington	District of Columbia	United States	20037
11	Manatee Memorial	Bradenton	Florida	United States	34209
12	Halifax Medical Center	Daytona Beach	Florida	United States	32114
13	Baptist Jacksonville	Jacksonville Beach	Florida	United States	32250
14	Mt. Sinai Medical Center	Miami Beach	Florida	United States	33140
15	Wuesthoff Hospital	Rockledge	Florida	United States	32955
16	Bayfront Medical Center	St. Petersburg	Florida	United States	33705
17	University of South Florida	Tampa	Florida	United States	33606
18	Florida Medical Center	Zephyrhills	Florida	United States	33542
19	Piedmont Hospital	Atlanta	Georgia	United States	30309
20	Emory University Clinic	Atlanta	Georgia	United States	30322
21	The University of Chicago	Chicago	Illinois	United States	60637
22	Loyola University	Maywood	Illinois	United States	60153
23	University of Kansas Hospital	Kansas City	Kansas	United States	66160
24	Central Baptist	Lexington	Kentucky	United States	40503
25	Louisiana Heart	Lafayette	Louisiana	United States	70503
26	Tulane University	New Orleans	Louisiana	United States	70112
27	University of Maryland	Baltimore	Maryland	United States	21201
28	Midatlantic Cardiovascular Associates	Baltimore	Maryland	United States	21218
29	Union Memorial Hospital	Baltimore	Maryland	United States	21218
30	Shady Grove Adventist	Rockville	Maryland	United States	20850
31	Tufts University	Boston	Massachusetts	United States	02111
32	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
33	New England Cardiovascular Specialists	Boston	Massachusetts	United States	02135
34	Lahey Clinic	Burlington	Massachusetts	United States	01805
35	North Shore Medical Center	Salem	Massachusetts	United States	01970
36	University of Michigan	Ann Arbor	Michigan	United States	48109
37	St. Joseph Mercy Hospital	Ypsilanti	Michigan	United States	48197
38	Forrest General Hospital	Hattiesburg	Mississippi	United States	39402
39	Mid America Heart	Kansas City	Missouri	United States	64111
40	Barnes Jewish Hospital	St. Louis	Missouri	United States	63110
41	Heart Consultants Omaha	Omaha	Nebraska	United States	68122
42	Alegent Hospitals	Omaha	Nebraska	United States	68124
43	Creighton University	Omaha	Nebraska	United States	68131
44	St. Barnabas	West Orange	New Jersey	United States	07052
45	Buffalo Heart Group	Buffalo	New York	United States	14214
46	St. Luke's Roosevelt Hospital	New York	New York	United States	10025
47	Duke University Medical Center	Durham	North Carolina	United States	27715
48	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
49	University of Cincinnati	Cincinnati	Ohio	United States	45267
50	University Hospitals Cleveland	Cleveland	Ohio	United States	44106
51	Heart and Vascular Center, MetroHealth MC	Cleveland	Ohio	United States	44109
52	Cleveland Clinic	Cleveland	Ohio	United States	44195
53	OU Medical Center Presbyterian	Oklahoma City	Oklahoma	United States	73104
54	Hillcrest Medical Center	Tulsa	Oklahoma	United States	74104
55	Sacred Heart Medical Center	Eugene	Oregon	United States	97401
56	Oregon Health Sciences University	Portland	Oregon	United States	97239
57	Abington Medical Specialists	Abington	Pennsylvania	United States	19454
58	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
59	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
60	Medical University of South Carolina	Charleston	South Carolina	United States	29403
61	South Carolina Heart Center	Columbia	South Carolina	United States	29204
62	Pee Dee Cardiology	Florence	South Carolina	United States	29506
63	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29307
64	Vanderbilt University	Nashville	Tennessee	United States	37232
65	Amarillo Heart	Amarillo	Texas	United States	79106
66	Christus Spohn	Corpus Christi	Texas	United States	78404
67	UT Southwestern	Dallas	Texas	United States	75390
68	Heart Center of North Texas	Fort Worth	Texas	United States	76104
69	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23502
70	University of Washington	Seattle	Washington	United States	98195
71	CAMC Memorial Hospital	Charleston	West Virginia	United States	25304

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

• Principal Investigator: Jeanne Poole, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT00395447
• Other Study ID Numbers: REPLACE
• First Posted: Nov 3, 2006
• Last Update Posted: Apr 14, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Biotronik, Inc.: Cardiac Pacemaker; Defibrillator; Replacement; Upgrade
• Additional relevant MeSH terms: Postoperative Complications

Study Results

Participant Flow

Arm/Group Title	'Straight-forward' Device Replacement	Replacement With Planned System Modification
Arm/Group Description	Cohort for patients undergoing a straight-forward device replacement without any planned system modification	Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
Period Title: Overall Study
STARTED	1031	713
COMPLETED	910	602
NOT COMPLETED	121	111

Baseline Characteristics

Arm/Group Title	'Straight-forward' Device Replacement	Replacement With Planned System Modification	Total
Arm/Group Description	Cohort for patients undergoing a straight-forward device replacement without any planned system modification	Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.	Total of all reporting groups
Overall Participants	1031	713	1744
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (14)	70 (13)	70 (14)
Sex: Female, Male (Count of Participants)
Female	389 37.7%	172 24.1%	561 32.2%
Male	642 62.3%	541 75.9%	1183 67.8%
Region of Enrollment (participants) [Number]
United States	1031 100%	713 100%	1744 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)
Description	The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	'Straight-forward' Device Replacement	Replacement With Planned System Modification
Arm/Group Description	Cohort for patients undergoing a straight-forward device replacement without any planned system modification	Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
Measure Participants	1031	713
Mean (95% Confidence Interval) [Percentage of participants (%)]	10.8 1%	20.9 2.9%

Adverse Events

Arm/Group Title	'Straight-forward' Device Replacement		Replacement With Planned System Modification
Arm/Group Description	Cohort for patients undergoing a straight-forward device replacement without any planned system modification		Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
All Cause Mortality
	'Straight-forward' Device Replacement		Replacement With Planned System Modification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	'Straight-forward' Device Replacement		Replacement With Planned System Modification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1031 (0%)		0/713 (0%)
Other (Not Including Serious) Adverse Events
	'Straight-forward' Device Replacement		Replacement With Planned System Modification
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1031 (0%)		0/713 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

All information obtained from BIOTRONIK or PharmaLink concerning the research ideas used in this study and all information obtained under or concerning this study is considered BIOTRONIK property. Investigator will maintain such information in confidence and not release it to anyone without written consent from BIOTRONIK or prior public disclosure, with the exception of information required by law or regulations to be disclosed to the reviewing IRB, the patient, or the FDA.