Guideline-based Pacing Therapy for Reflex Syncope

NCT01509534 | Completed DMC

• 1 other identifier: GIMSI-001-2011
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 8

Brief Summary

Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence or the total syncope burden.

Conditions

Syncope

Keywords

pacemaker; implantable loop recorder; syncope

Outcome Measures

Primary Outcomes (1)

• syncope recurrence after PM implantation

  1 year

Secondary Outcomes (1)

• syncope burden after PM implantation

  1 year

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by reflex syncopes

You may qualify if:

• Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years.

You may not qualify if:

• Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc
• Suspected of certain cardiac syncope
• Syncope caused by orthostatic hypotension
• Non-syncopal causes of transient loss of consciousness

Sponsors & Collaborators

• Gruppo Italiano Multidisciplinare per lo Studio della Sincope: lead

Study Sites (8)

Ospedale Generale Regionale

Bolzano, Italy

Location

AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi

Catania, Italy

Location

PO S. Giuseppe

Empoli, Italy

Location

AO Careggi

Florence, Italy

Location

Nuovo Ospedale S. Giovanni di Dio

Florence, Italy

Location

Department of Cardiology, Ospedali del Tigullio

Lavagna, 16033, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

Ospedale SS. Annunziata

Taranto, Italy

Location

Related Publications (3)

• Solari D, Tesi F, Unterhuber M, Gaggioli G, Ungar A, Tomaino M, Brignole M. Stop vasodepressor drugs in reflex syncope: a randomised controlled trial. Heart. 2017 Mar;103(6):449-455. doi: 10.1136/heartjnl-2016-309865. Epub 2016 Sep 23.

  PMID: 27664002 DERIVED

• Brignole M, Arabia F, Ammirati F, Tomaino M, Quartieri F, Rafanelli M, Del Rosso A, Rita Vecchi M, Russo V, Gaggioli G; Syncope Unit Project 2 (SUP 2) investigators. Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study. Europace. 2016 Sep;18(9):1427-33. doi: 10.1093/europace/euv343. Epub 2015 Nov 26.

  PMID: 26612880 DERIVED

• Brignole M, Ammirati F, Arabia F, Quartieri F, Tomaino M, Ungar A, Lunati M, Russo V, Del Rosso A, Gaggioli G; Syncope Unit Project (SUP) Two Investigators. Assessment of a standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncopes. Eur Heart J. 2015 Jun 21;36(24):1529-35. doi: 10.1093/eurheartj/ehv069. Epub 2015 Mar 29.

  PMID: 25825044 DERIVED

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

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

Study Officials

• Michele Brignole, MD

  Ospedali del Tigullio, Lavagna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: January 13, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

IT (8)