Reveal In-Office Implants

NCT01168427 | Completed Results

• 1 other identifier: Reveal In-Office Implants
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

• Procedure-related Complications Rate Requiring Resolution by Surgical Intervention

  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.

  From Implant to 90 days post-implant procedure

Secondary Outcomes (5)

• Number of Participants Having Procedure-related Adverse Events

  From Implant to 90 days post-implant procedure

• Surgical Staff Utilized for Reveal In-office Implants

  At implant

• Techniques and Procedures Utilized During Reveal In-office Implants

  At implant

• Physician Satisfaction With Reveal In-office Implants

  At implant

• R-wave Amplitude Measurement

  Implant procedure and 30 days post-implant procedure

Interventions

Reveal® DX or Reveal® XT Insertable Cardiac Monitor DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients recruited for participation in study were indicated for continuous arrhythmia monitoring.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Macon, Georgia, United States

Location

Unknown Facility

Munster, Indiana, United States

Location

Unknown Facility

Takoma Park, Maryland, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Kettering, Ohio, United States

Location

Unknown Facility

Amarillo, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (28)

• 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. doi: 10.1161/01.cir.99.3.406.

  PMID: 9918528 BACKGROUND

• 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. doi: 10.1016/j.ehj.2004.05.013.

  PMID: 15231369 BACKGROUND

• Krahn AD, Klein GJ, Yee R, Skanes AC. Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J. 2004 Aug;148(2):326-32. doi: 10.1016/j.ahj.2004.01.024.

  PMID: 15309004 BACKGROUND

• 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. doi: 10.1161/hc3601.095708.

  PMID: 11551877 BACKGROUND

• 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. doi: 10.1001/archderm.140.11.1379.

  PMID: 15545548 BACKGROUND

• 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. doi: 10.1161/01.cir.92.7.1819.

  PMID: 7671366 BACKGROUND

• 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. doi: 10.1016/s0002-9149(98)00237-9.

  PMID: 9671019 BACKGROUND

• Seidl K, Breunung S, Rameken M, Siemon G, Schwacke H, Drogemuller 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. doi: 10.1007/s003920050007. German.

  PMID: 10663916 BACKGROUND

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

  PMID: 11731693 BACKGROUND

• 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. doi: 10.1046/j.1460-9592.2002.00037.x.

  PMID: 11877934 BACKGROUND

• 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. doi: 10.1093/ageing/32.2.185.

  PMID: 12615562 BACKGROUND

• 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.

  PMID: 15008063 BACKGROUND

• 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. doi: 10.1016/j.amjcard.2003.07.011.

  PMID: 14583373 BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)02621-9.

  PMID: 12570950 BACKGROUND

• 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. doi: 10.1016/s0002-9149(03)00889-0.

  PMID: 14516882 BACKGROUND

• 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. doi: 10.1016/j.ijcard.2003.06.020.

  PMID: 15676163 BACKGROUND

• 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. doi: 10.1016/j.eupc.2004.09.003.

  PMID: 15670962 BACKGROUND

• 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.

  PMID: 16816436 BACKGROUND

• 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. doi: 10.1093/europace/eum092. Epub 2007 May 16.

  PMID: 17507364 BACKGROUND

• 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. doi: 10.1093/europace/eup361.

  PMID: 19914920 BACKGROUND

• 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. doi: 10.1378/chest.126.4.1177.

  PMID: 15486380 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.04.063. Epub 2005 Sep 23.

  PMID: 16226180 BACKGROUND

• 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. doi: 10.1161/hc3401.095097.

  PMID: 11524397 BACKGROUND

• Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W, Andresen D, Benditt DG, Vardas P; International Study on Syncope of Uncertain Etiology 2 (ISSUE 2) Group. Early application of an implantable loop recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. 2006 May;27(9):1085-92. doi: 10.1093/eurheartj/ehi842. Epub 2006 Mar 28.

  PMID: 16569653 BACKGROUND

• 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. doi: 10.1161/hc4201.097837.

  PMID: 11673344 BACKGROUND

• 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. doi: 10.1161/01.cir.0000018125.31973.87.

  PMID: 12057988 BACKGROUND

• Vater M., Rameken M., Pitschner H.F., et al. The endless-loop-recorder in clinical practice - Results of the multicentre German Reveal® registry. Herzschrittmachertherapie und Elektrophysiologie (2002) 13:2 (101-109).

  BACKGROUND

• Pachulski R, Cockrell J, Solomon H, Yang F, Rogers J. Implant evaluation of an insertable cardiac monitor outside the electrophysiology lab setting. PLoS One. 2013 Aug 15;8(8):e71544. doi: 10.1371/journal.pone.0071544. eCollection 2013.

  PMID: 23977071 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: RIO Clinical Research Specialist.
• Organization: Medtronic - CRDM

MedtronicCRMtrials@medtronic.com

1-800-328-2518

Study Officials

• Reveal In-Office Implants Clinical Research Specialist

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 23, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 28, 2018
• Results First Posted: July 26, 2012

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)