Cardiac Resynchronization TherapySCOPE-CRTNCT03301363
Simultaneous or Sequential Multipoint Pacing
An observational study of Cardiac Resynchronization Therapy, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- CRT
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Concomitant diseases that would substantially limit a positive prognosis
- Accelerated intrinsic rhythm
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097
Carlo Pappone, MD, PhD, 00390252774260, carlo.pappone@af-ablation.org
About this study
Official title: Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
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.
Read the 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.
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- CRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTDevice
Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute QRS duration changes during multipoint CRT
Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.
Measured: 1 day during CRT
Secondary outcomes (2)
Acute ECG QRS duration changes during multipoint CRT
Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing.
•
Measured: 1 day during CRT
Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint 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.
Measured: 1 day during CRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start30 Nov 2017
- Primary completion28 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Pappone, IRCCS Policlinico S. Donato
- Investigators
- Carlo Pappone, MD, Principal investigator, IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301363
- Sponsor's protocol ID
- SCOPE-CRT IRCCSDonato
- Acronym
- SCOPE-CRT
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2017
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03301363
- Acronym / sponsor ID
- SCOPE-CRT / SCOPE-CRT IRCCSDonato
- Conditions
- Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Myocardial infarction within 40 days before enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRTSubjects scheduled to be implanted for CRT by a Quadripolar Pacing System | Device | – |
Primary outcome
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.
2 secondary outcomes
Acute ECG QRS duration changes during multipoint CRT
Time frame: 1 day during CRT
Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT
Time frame: 1 day during CRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Pappone, MD principal investigator
IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Resynchronization Therapy, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Santinelli, MD (+39 0252774260, vincenzo.santinelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute QRS duration changes during multipoint CRT (time frame: 1 day during CRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.