Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain

NCT03184233 | Completed DMC

• 1 other identifier: 17/16/205
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.

Conditions

Cardiac Pacing, Artificial; Aneurysm, Brain; Arteriovenous Malformations, Cerebral

Outcome Measures

Primary Outcomes (2)

• Near infrared spectroscopy

  Near infrared spectroscopy measures brain oxygenation (Sct O2), a decrease of more than 10% of the initial Sct O2 or lower than 60% during pacing will be considered as a possible risk of cerebral ischaemia.

  During surgery

• Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample(baseline)

  For detection of myocardial injury, the cardiac specific enzyme Troponin (cTnl) is evaluated pre-and postoperatively.

  A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 6,12 and 24 hours after start surgery.

Secondary Outcomes (2)

• Magnetic resonance imaging

  Preoperative and within 1 week post surgery

• Occurence of arrhythmias

  During surgery

Study Arms (2)

Cerebral aneurysm surgery with RVP

OTHER

Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. During surgery subjects allocated in this study arm will undergo RVP.

Procedure: Rapid ventricular pacing

Craniotomy without RVP

ACTIVE COMPARATOR

Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. No rapid ventricular pacing is applied perioperatively.

Procedure: No rapid ventricular pacing

Interventions

Rapid ventricular pacing PROCEDURE

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture

Cerebral aneurysm surgery with RVP

No rapid ventricular pacing PROCEDURE

No rapid ventricular pacing is applied perioperatively.

Craniotomy without RVP

Eligibility Criteria

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

You may qualify if:

• elective cerebral aneurysm clipping surgery
• arteriovenous malformation surgery
• craniotomy
• American Society of Anesthesiologists 1,2 and 3

You may not qualify if:

• cardiac abnormalities
• coronary heart disease
• valvular heart disease
• pregnancy

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vera Saldien, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

• Tomas Menovsky, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Data manager

Model Details: Patients undergoing elective cerebral aneurysm clipping surgery or arteriovenous malformation surgery will be asked to take part and give informed consent. A control group of patients undergoing craniotomy without the use of RVP will be built in, having the same exclusion criteria. Both study groups receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 12, 2017
• Study Start: June 14, 2017
• Primary Completion: June 12, 2022
• Study Completion: January 17, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

BE (1)