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Simultaneous or Sequential Multipoint Pacing (SCOPE-CRT)

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: NCT03301363
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Brief Summary:
The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable delays setting during MPP pacing.

Condition or disease Intervention/treatment
Cardiac Resynchronization Therapy Device: CRT

Detailed Description:

The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripolar Pacing System who provide informed consent will undergo "Enrollment" and participate in "SCOPE-CRT" study. Enrollment and device implant can occur in the same day. Including Enrollment, each subject's participation is expected to be 1-2 days. The total duration of the study is expected to be 12 months, including Enrollment. Enrollment will include the Informed Consent process, physical examination, and collection of demographics, cardiovascular history, medical history, and medications.

During CRT implant, surface ECG and PV loop recordings will be taken over the different programmable MPP settings. Following data collection, CRT device programming will be left to the discretion of the physician.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Intervention Details:
  • Device: CRT
    Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System


Primary Outcome Measures :
  1. Acute QRS duration changes during multipoint CRT [ Time Frame: 1 day during CRT ]
    Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.


Secondary Outcome Measures :
  1. Acute ECG QRS duration changes during multipoint CRT [ Time Frame: 1 day during CRT ]

    Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing.


  2. Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT [ Time Frame: 1 day during CRT ]
    Quantify acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT pacing over a range of inter- and intra-ventricular programmable delays settings.



Information from the National Library of Medicine

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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
A total of 50 selected heart failure patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA) will be enrolled for this prospective study.
Criteria

Inclusion Criteria:

  • Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA)
  • QRS duration > 130 ms
  • Ability to provide informed consent for study participation
  • At least 18 years of age

Exclusion Criteria:

  • Myocardial infarction within 40 days before enrolment

    • NYHA Class IV
    • Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
    • Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries
    • VT with few or without clinically relevant symptoms
    • VT or VF treatable by surgery
    • Concomitant diseases that would substantially limit a positive prognosis
    • Accelerated intrinsic rhythm
    • Women who are pregnant

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): NCT03301363


Contacts
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Contact: Vincenzo Santinelli, MD +39 0252774260 vincenzo.santinelli@gmail.com
Contact: Carlo Pappone, MD +39 0252774260 carlo.pappone@af-ablation.org

Locations
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Italy
IRCCS Policlinico S. Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Carlo Pappone, MD, PhD    00390252774260    carlo.pappone@af-ablation.org   
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Carlo Pappone, MD IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
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Responsible Party: Carlo Pappone, Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03301363    
Other Study ID Numbers: SCOPE-CRT IRCCSDonato
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No