Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy

NCT03876652 | Completed DMC

• 1 other identifier: 719
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Vasovagal syncope is an entity frequently in the emergency services, its treatment includes pharmacological and non-pharmacological measures, and in some severe cases, requires the implantation of cardiac stimulation devices, specifically, those pacemakers that have closed-loop sensors (CLS). This research is an intervention study, multi-institutional, randomized and double blind that will be carried out in patients older than 18 years, with a diagnosis of neurally mediated type 1, 2A or 2B syncope documented in a tilting table test, who have had at least 2 syncope in the last year and that significantly affects the quality of life despite the use of pharmacological and non-pharmacological non-interventionist therapy. This study aims to evaluate the effect of cardiac pacing therapy with CLS pacemakers on quality of life, recurrence of syncope and pre-syncopal symptoms in patients with a diagnosis of neurally mediated syncope in this group of patients.

Conditions

Syncope

Keywords

Syncope; Presyncope; Time; Vasovagal; Unconsciousness

Outcome Measures

Primary Outcomes (3)

• Change in the quality of life with pacemaker CLS with Syncope Functional Status health-related quality of life Questionnarie (SFSQ).

  To evaluate the results of pacemaker therapy with pacemaker with CLS in the quality of life, the score of the scales is compared: SFSQ of implanting the pacemaker, a statistical analysis with tests is performed paired. The quality of life questionnaire consists of several domains consisting of questions that evaluate the parameters of daily life with multiple-choice questions with a single answer. At the end of the questionnaire, each question in its domain of a score and once each domain has a representation in the final qualification.

  21 months

• Change in the quality of life with pacemaker CLS with the score Short Form - 36 (SF-36).

  To evaluate the results of pacemaker therapy with pacemaker with CLS in the quality of life, the score of the scales is compared: SF-36 (Short form - 36) of implanting the pacemaker, a statistical analysis with tests is performed paired. The quality of life questionnaire consists of several domains consisting of questions that evaluate the parameters of daily life with multiple-choice questions with a single answer. At the end of the questionnaire, each question in its domain of a score and once each domain has a representation in the final qualification.

  21 months

• Change of number of syncopes

  Change in the number of syncopes with the use of CLS pacemakers in participants with neuromediated syncope

  21 months

Secondary Outcomes (6)

• Change in free time of syncope

  21 months

• Presence or absence of pre-syncopal symptoms: postural dizziness

  21 months

• Presence or absence of pre-syncopal symptoms: fatigue

  21 months

• Presence or absence of pre-syncopal symptoms: headache

  21 months

• Presence or absence of pre-syncopal symptoms: sleep disturbance

  21 months

Other Outcomes (1)

• Demographic characteristics

  21 months

Study Arms (2)

DDD-CLS

EXPERIMENTAL

Patients with a pacemaker programmed in DDD-CLS mode

Device: Pacemaker with Closed Loop Stimulation (CLS)

DDD-R

ACTIVE COMPARATOR

Patients with a pacemaker programmed in DDD-R mode

Device: Pacemaker with Closed Loop Stimulation (CLS)

Interventions

Pacemaker with Closed Loop Stimulation (CLS) DEVICE

In active mode of closed loop sensor (CLS), evaluate its impact on quality of life and recurrence of syncope.

DDD-CLS; DDD-R

Eligibility Criteria

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

You may qualify if:

• Over 18 years.
• Diagnosis of neurally mediated syncope with a tilting table test (Tilt test) that demonstrates a mixed (type 1) or cardioinhibitory response (Type 2A and 2B).
• Negative impact on work and social life.
• Non-respondent to pharmacological therapy (Fludrocortisone 0.1mg / 24 hours for 3 months) and non-pharmacological (exercise, hydration and consumption of more than 3 months) is due to a cardiologist who has performed a strict stricture over time.
• At least 2 episodes of syncope in the last year.

You may not qualify if:

• Complete atrioventricular block.
• Second degree ventricular atrial block.
• Bradycardia syndrome - tachycardia.
• Disease of the sinus node.
• Arrhythmia (bradycardia or tachycardia that generate syncope and / or low cardiac output).
• Syncope due to hypersensitivity of the carotid sinus.
• Syncope with Tilt Test that demonstrates depressant vasopressor response (type 3).
• Refusal of the patient, his relatives or the attending physician to participate in the study.

Sponsors & Collaborators

• CES University: lead

Study Sites (2)

CES Cardiología sede Sandiego

Medellín, Antioquia, 05001, Colombia

Location

Clínica CES

Medellín, Antioquia, 05001, Colombia

Location

Related Publications (19)

• Linzer M, Pontinen M, Gold DT, Divine GW, Felder A, Brooks WB. Impairment of physical and psychosocial function in recurrent syncope. J Clin Epidemiol. 1991;44(10):1037-43. doi: 10.1016/0895-4356(91)90005-t.

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• van Dijk N, Sprangers MA, Boer KR, Colman N, Wieling W, Linzer M. Quality of life within one year following presentation after transient loss of consciousness. Am J Cardiol. 2007 Aug 15;100(4):672-6. doi: 10.1016/j.amjcard.2007.03.085. Epub 2007 Jun 26.

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• Goyal P, Maurer MS. Syncope in older adults. J Geriatr Cardiol. 2016 Jul;13(5):380-6. doi: 10.11909/j.issn.1671-5411.2016.05.002. No abstract available.

  PMID: 27594863 BACKGROUND

• Blanc JJ. Syncope: Definition, Epidemiology, and Classification. Cardiol Clin. 2015 Aug;33(3):341-5. doi: 10.1016/j.ccl.2015.04.001.

  PMID: 26115819 BACKGROUND

• Rosanio S, Schwarz ER, Ware DL, Vitarelli A. Syncope in adults: systematic review and proposal of a diagnostic and therapeutic algorithm. Int J Cardiol. 2013 Jan 20;162(3):149-57. doi: 10.1016/j.ijcard.2011.11.021. Epub 2011 Dec 20.

  PMID: 22188993 BACKGROUND

• Bassetti CL. Transient loss of consciousness and syncope. Handb Clin Neurol. 2014;119:169-91. doi: 10.1016/B978-0-7020-4086-3.00013-8.

  PMID: 24365296 BACKGROUND

• van Dijk N, Sprangers MA, Colman N, Boer KR, Wieling W, Linzer M. Clinical factors associated with quality of life in patients with transient loss of consciousness. J Cardiovasc Electrophysiol. 2006 Sep;17(9):998-1003. doi: 10.1111/j.1540-8167.2006.00533.x. Epub 2006 Jun 9.

  PMID: 16764705 BACKGROUND

• Occhetta E, Bortnik M, Audoglio R, Vassanelli C; INVASY Study Investigators. Closed loop stimulation in prevention of vasovagal syncope. Inotropy Controlled Pacing in Vasovagal Syncope (INVASY): a multicentre randomized, single blind, controlled study. Europace. 2004 Nov;6(6):538-47. doi: 10.1016/j.eupc.2004.08.009.

  PMID: 15519257 BACKGROUND

• Russo V, Rago A, Papa AA, Golino P, Calabro R, Russo MG, Nigro G. The effect of dual-chamber closed-loop stimulation on syncope recurrence in healthy patients with tilt-induced vasovagal cardioinhibitory syncope: a prospective, randomised, single-blind, crossover study. Heart. 2013 Nov;99(21):1609-13. doi: 10.1136/heartjnl-2013-303878. Epub 2013 May 30.

  PMID: 23723446 BACKGROUND

• Connolly SJ, Sheldon R, Roberts RS, Gent M. The North American Vasovagal Pacemaker Study (VPS). A randomized trial of permanent cardiac pacing for the prevention of vasovagal syncope. J Am Coll Cardiol. 1999 Jan;33(1):16-20. doi: 10.1016/s0735-1097(98)00549-x.

  PMID: 9935002 BACKGROUND

• Sutton R, Ungar A, Sgobino P, Russo V, Massa R, Melissano D, Beiras X, Bottoni N, Ebert HH, Francese M, Jorfida M, Giuli S, Moya A, Andresen D, Brignole M; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Cardiac pacing in patients with neurally mediated syncope and documented asystole: effectiveness analysis from the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) Registry. Europace. 2014 Apr;16(4):595-9. doi: 10.1093/europace/eut323. Epub 2014 Jan 9.

  PMID: 24406537 BACKGROUND

• Brignole M. International study on syncope of uncertain aetiology 3 (ISSUE 3): pacemaker therapy for patients with asystolic neurally-mediated syncope: rationale and study design. Europace. 2007 Jan;9(1):25-30. doi: 10.1093/europace/eul135.

  PMID: 17224418 BACKGROUND

• Brignole M, Menozzi C, Moya A, Andresen D, Blanc JJ, Krahn AD, Wieling W, Beiras X, Deharo JC, Russo V, Tomaino M, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial. Circulation. 2012 May 29;125(21):2566-71. doi: 10.1161/CIRCULATIONAHA.111.082313. Epub 2012 May 7.

  PMID: 22565936 BACKGROUND

• Palmisano P, Zaccaria M, Luzzi G, Nacci F, Anaclerio M, Favale S. Closed-loop cardiac pacing vs. conventional dual-chamber pacing with specialized sensing and pacing algorithms for syncope prevention in patients with refractory vasovagal syncope: results of a long-term follow-up. Europace. 2012 Jul;14(7):1038-43. doi: 10.1093/europace/eur419. Epub 2012 Jan 13.

  PMID: 22247273 BACKGROUND

• Lindovska M, Kamenik L, Pollock B, Hoenen S, Bokelmann T, Spitzer W, Salbach P, Behroz A, Frey A. Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS routine documentation registry (RECORD). Europace. 2012 Nov;14(11):1587-95. doi: 10.1093/europace/eus062. Epub 2012 Mar 28.

  PMID: 22455935 BACKGROUND

• Occhetta E, Bortnik M, Vassanelli C; INVASY Italian Feasibility Study Group. The DDDR closed loop stimulation for the prevention of vasovagal syncope: results from the INVASY prospective feasibility registry. Europace. 2003 Apr;5(2):153-62. doi: 10.1053/eupc.2002.0292.

  PMID: 12633640 BACKGROUND

• Bortnik M, Occhetta E, Dell'Era G, Secco GG, Degiovanni A, Plebani L, Marino P. Long-term follow-up of DDDR closed-loop cardiac pacing for the prevention of recurrent vasovagal syncope. J Cardiovasc Med (Hagerstown). 2012 Apr;13(4):242-5. doi: 10.2459/JCM.0b013e328351daf5.

  PMID: 22367575 BACKGROUND

• Kanjwal K, Karabin B, Kanjwal Y, Grubb BP. Preliminary observations on the use of closed-loop cardiac pacing in patients with refractory neurocardiogenic syncope. J Interv Card Electrophysiol. 2010 Jan;27(1):69-73. doi: 10.1007/s10840-009-9452-1. Epub 2009 Nov 25.

  PMID: 19937372 BACKGROUND

• Puppala VK, Dickinson O, Benditt DG. Syncope: classification and risk stratification. J Cardiol. 2014 Mar;63(3):171-7. doi: 10.1016/j.jjcc.2013.03.019. Epub 2014 Jan 7.

  PMID: 24405895 BACKGROUND

Related Links

• Use of closed loop sensor pacing system in patients with vasovagal syncope refractory to medical treatment
• Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study) (SPAIN)

MeSH Terms

Conditions

Syncope; Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mauricio Duque

Model Details: Prospective, multi-institutional, randomized, double-blind intervention study. Patients with a diagnosis of cardioinhibitory syncope will be included. They have implanted a pacemaker with a closed loop sensor. Pacemakers are left in CLS mode during the first month, the month in the implant is cited patients and the random form is left reprogrammed in DDD-R or DDD-CLS mode as randomization is established. After 4 months of this last visit, the reprogramming mode will be exchanged and left for another 4 months. During this time, a clinical and electrophysiological evaluation will be performed. At the end of these 8 months, the patient will be rescheduled in the same electrophysiologist's mode as the patient has felt better. The clinical follow-up will continue for 12 more months. At the end of the study, the results of the quality of life scales will be analyzed, the occurrence of episodes of syncope, the reduction of pre-syncopal symptoms, mode and programming will be evaluated.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 15, 2019
• Study Start: November 22, 2017
• Primary Completion: April 15, 2021
• Study Completion: March 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

CO (2)