Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias (A PRIORY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631303
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Cornelis P. Allaart, VU University Medical Center

Brief Summary:

Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small proportion of ICD patients receives appropriate device therapy (ATP or a shock) during follow-up. Post-extrasystolic potentiation (PESP) may be a new risk marker for SCD. PESP is defined as a temporary increase in contractility that follows an extrasystolic beat (ESB) and is associated with myocardial calcium handling. In heart failure, changes in calcium homeostasis may lead to afterdepolarisations and thus predispose for SCD. PESP can be measured indirectly and non-invasively as post-extrasystolic blood pressure potentiation (PESP-BP). Abnormal PESP-BP was previously found to be an independent predictor of increased mortality in post-myocardial infarction patients with a reduced LVEF. However, it is unknown if this increased mortality in heart failure patients with abnormal PESP-BP is caused by an increased risk of SCD.

Hypothesis: The investigators hypothesize that PESP-BP might be a new predictor of the occurrence of SCD, and can be used to enhance patient selection for primary prevention ICD therapy.

Design: During scheduled device replacement ESB with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively a continuous electrocardiogram will be recorded. Either before or after the procedure, patients will undergo a 30-minutes assessment of spontaneous ESB, again with blood pressure and ECG recordings.

Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ADT); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group).

Outcomes: (1) Evoked PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (2) Spontaneous PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (3) Timing parameters (in ms): the basic cycle length interval; Extra-systolic interval (ESI); Post-extrasystolic interval (PESI).


Condition or disease Intervention/treatment
Post-extrasystolic Potentiation (PESP) Ventricular Tachycardia Device: Cardiac stimulation through the device leads

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ICD patients with ATP/shock
10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who received appropriate ICD therapy during follow-up.
Device: Cardiac stimulation through the device leads
During scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded.

ICD patients without ATP/Shock
10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who were free from appropriate ICD therapy during follow-up.
Device: Cardiac stimulation through the device leads
During scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded.

Pacemaker-patients
10 2-chamber pacemaker-patients (LVEF >50%).
Device: Cardiac stimulation through the device leads
During scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded.




Primary Outcome Measures :
  1. Evoked PESP-BP [ Time Frame: Measured during stimulation protocol ]
    blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB

  2. Spontaneous PESP-BP [ Time Frame: Measured in rest, without cardiac stimulation with spontaneous ESB ]
    blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ATP/shock); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group)
Criteria

Inclusion Criteria:

  • Implanted with a dual-chamber device
  • For ICD patients: a LVEF ≤35%, measured recently
  • For Pacemaker patients: a LVEF > 50% measured both recently
  • A device follow-up of at least one year must be available
  • Optimal (stable) medical therapy
  • Sinus rhythm

Exclusion Criteria:

  • Age <18 or incapacitated adult
  • Unknown left ventricular function prior to device implantation
  • Patients unwilling to participate
  • Documented atrial fibrillation
  • Second or third degree atrioventricular (AV) conduction disorders;
  • Patients with a cardiac resynchronization therapy (CRT-D) or one-chamber device
  • Hypertrophic cardiomyopathy
  • Conditions with insufficient blood flow to the fingers, e.g. M. Raynaud or conditions with extreme vasoconstriction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631303


Contacts
Layout table for location contacts
Contact: Cornelis P Allaart, MD, PhD +31 (0)20 4445043 cp.allaart@vumc.nl
Contact: Anne-Lotte CJ van der Lingen, MD +31 (0)20-4443272 a.vanderlingen@vumc.nl

Locations
Layout table for location information
Netherlands
VU university medical center Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Anne-Lotte van der Lingen, MD    +31204443272    a.vanderlingen@vumc.nl   
Sponsors and Collaborators
VU University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Cornelis P. Allaart, MD, PhD VU University Medical Center

Publications:
Layout table for additonal information
Responsible Party: Cornelis P. Allaart, Principal Investigator, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03631303     History of Changes
Other Study ID Numbers: 2018.246
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cornelis P. Allaart, VU University Medical Center:
Implantable cardioverter defibrillator
Post-extrasystolic Potentiation
Sudden Cardiac Death
Additional relevant MeSH terms:
Layout table for MeSH terms
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes