Reveal In-Office Implants - Full Text View

Purpose

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.

Condition	Intervention
Arrhythmias, Cardiac	Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Reveal® In-Office Implants Study

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Procedure-related Complications Rate Requiring Resolution by Surgical Intervention [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

Secondary Outcome Measures:

Number of Participants Having Procedure-related Adverse Events [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).
Surgical Staff Utilized for Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
Observational analysis of surgical staff present at the Reveal Implants
Techniques and Procedures Utilized During Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.
Physician Satisfaction With Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
Observational survey of physicians satisfaction post implant At implant
R-wave Amplitude Measurement [ Time Frame: Implant procedure and 30 days post-implant procedure ] [ Designated as safety issue: No ]
Average R-wave amplitude at implant and 30-days post procedure

Enrollment:	66
Study Start Date:	August 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is indicated for continuous arrhythmia monitoring with an Insertable Cardiac Monitor (ICM)
Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation
Patient is 18 years of age or older
Patient is willing and able to provide consent and authorize the use and disclosure of health information
Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

Patient has reduced immune function or is otherwise at high risk for infection
Patient has had a recent (within 30 days) or otherwise unresolved infection
Patient is implanted or indicated for implant with a pacemaker, Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system
Patient is participating in another clinical study that may have an impact on the study endpoints
Patient's life expectancy is less than 1 year
Patient is pregnant
Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168427

Locations

United States, California

La Jolla, California, United States
United States, Florida

Miramar, Florida, United States
United States, Georgia

Macon, Georgia, United States
United States, Indiana

Munster, Indiana, United States
United States, Maryland

Takoma Park, Maryland, United States
United States, North Carolina

Greensboro, North Carolina, United States
United States, Ohio

Kettering, Ohio, United States
United States, Texas

Amarillo, Texas, United States

San Antonio, Texas, United States

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Study Chair:

Reveal In-Office Implants Clinical Research Specialist

Medtronic

More Information

Publications:

Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. 1999 Jan 26;99(3):406-10.

Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9.

Krahn AD, Klein GJ, Yee R, Skanes AC. Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J. 2004 Aug;148(2):326-32.

Moya A, Brignole M, Menozzi C, Garcia-Civera R, Tognarini S, Mont L, Botto G, Giada F, Cornacchia D; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with isolated syncope and in patients with tilt-positive syncope. Circulation. 2001 Sep 11;104(11):1261-7.

Hancox JG, Venkat AP, Coldiron B, Feldman SR, Williford PM. The safety of office-based surgery: review of recent literature from several disciplines. Arch Dermatol. 2004 Nov;140(11):1379-82. Review.

Krahn AD, Klein GJ, Norris C, Yee R. The etiology of syncope in patients with negative tilt table and electrophysiological testing. Circulation. 1995 Oct 1;92(7):1819-24.

Krahn AD, Klein GJ, Yee R, Norris C. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing. Am J Cardiol. 1998 Jul 1;82(1):117-9.

Seidl K, Breunung S, Rameken M, Siemon G, Schwacke H, Drögemüller A, Zahn R, Senges J. [Initial experience with an implantable loop recorder in patients with unexplained syncope] Z Kardiol. 2000 Jan;89(1):43-50. German.

Mieszczanska H, Ibrahim B, Cohen TJ. Initial clinical experience with implantable loop recorders. J Invasive Cardiol. 2001 Dec;13(12):802-4.

Krahn AD, Klein GJ, Fitzpatrick A, Seidl K, Zaidi A, Skanes A, Yee R. Predicting the outcome of patients with unexplained syncope undergoing prolonged monitoring. Pacing Clin Electrophysiol. 2002 Jan;25(1):37-41.

Armstrong VL, Lawson J, Kamper AM, Newton J, Kenny RA. The use of an implantable loop recorder in the investigation of unexplained syncope in older people. Age Ageing. 2003 Mar;32(2):185-8.

Sanfins V, Chaves JC, Alves A, Silva F, Machado I, Quelhas I, Medeiros R, Pires R, Reis D, Pereira A, de Almeida J. Use of an implantable loop recorder: initial experience. Rev Port Cardiol. 2003 Dec;22(12):1479-83. English, Portuguese.

Mason PK, Wood MA, Reese DB, Lobban JH, Mitchell MA, DiMarco JP. Usefulness of implantable loop recorders in office-based practice for evaluation of syncope in patients with and without structural heart disease. Am J Cardiol. 2003 Nov 1;92(9):1127-9.

Donateo P, Brignole M, Menozzi C, Bottoni N, Alboni P, Dinelli M, Del Rosso A, Croci F, Oddone D, Solano A, Puggioni E. Mechanism of syncope in patients with positive adenosine triphosphate tests. J Am Coll Cardiol. 2003 Jan 1;41(1):93-8.

Ermis C, Zhu AX, Pham S, Li JM, Guerrero M, Vrudney A, Hiltner L, Lu F, Sakaguchi S, Lurie KG, Benditt DG. Comparison of automatic and patient-activated arrhythmia recordings by implantable loop recorders in the evaluation of syncope. Am J Cardiol. 2003 Oct 1;92(7):815-9.

Paisey JR, Yue AM, Treacher K, Roberts PR, Morgan JM. Implantable loop recorders detect tachyarrhythmias in symptomatic patients with negative electrophysiological studies. Int J Cardiol. 2005 Jan;98(1):35-8.

Lombardi F, Calosso E, Mascioli G, Marangoni E, Donato A, Rossi S, Pala M, Foti F, Lunati M. Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope. Europace. 2005 Jan;7(1):19-24.

Inamdar V, Mehta S, Juang G, Cohen T. The utility of implantable loop recorders for diagnosing unexplained syncope in 100 consecutive patients: five-year, single-center experience. J Invasive Cardiol. 2006 Jul;18(7):313-5.

Maggi R, Menozzi C, Brignole M, Podoleanu C, Iori M, Sutton R, Moya A, Giada F, Orazi S, Grovale N. Cardioinhibitory carotid sinus hypersensitivity predicts an asystolic mechanism of spontaneous neurally mediated syncope. Europace. 2007 Aug;9(8):563-7. Epub 2007 May 16.

Pakarinen S, Oikarinen L, Toivonen L. Short-term implantation-related complications of cardiac rhythm management device therapy: a retrospective single-centre 1-year survey. Europace. 2010 Jan;12(1):103-8.

Wiegand UK, LeJeune D, Boguschewski F, Bonnemeier H, Eberhardt F, Schunkert H, Bode F. Pocket hematoma after pacemaker or implantable cardioverter defibrillator surgery: influence of patient morbidity, operation strategy, and perioperative antiplatelet/anticoagulation therapy. Chest. 2004 Oct;126(4):1177-86.

Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol. 2005 Oct 18;46(8):1536-40. Epub 2005 Sep 23. Erratum in: J Am Coll Cardiol. 2005 Nov 15;46(10):1964.

Chamis AL, Peterson GE, Cabell CH, Corey GR, Sorrentino RA, Greenfield RA, Ryan T, Reller LB, Fowler VG Jr. Staphylococcus aureus bacteremia in patients with permanent pacemakers or implantable cardioverter-defibrillators. Circulation. 2001 Aug 28;104(9):1029-33.

Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W, Andresen D, Benditt DG, Vardas P. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006 Mar 28; [Epub ahead of print]

Brignole M, Menozzi C, Moya A, Garcia-Civera R, Mont L, Alvarez M, Errazquin F, Beiras J, Bottoni N, Donateo P; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with bundle branch block and negative electrophysiological test. Circulation. 2001 Oct 23;104(17):2045-50.

Menozzi C, Brignole M, Garcia-Civera R, Moya A, Botto G, Tercedor L, Migliorini R, Navarro X; International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with heart disease and negative electrophysiologic test. Circulation. 2002 Jun 11;105(23):2741-5.

Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT01168427 History of Changes
Other Study ID Numbers:	Reveal In-Office Implants
Study First Received:	July 21, 2010
Results First Received:	June 19, 2012
Last Updated:	August 27, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013