First Degree Atrioventricular BlockREAL-CRTNCT02150538
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
A study testing Cardiac resynchronization therapy pacemaker and Dual chamber pacemaker in people with First Degree Atrioventricular Block, run by Gianluca Botto at 1 site in Italy.
Trial summary
This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the treatment with dual-chamber device . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Degree Atrioventricular Block
- What is being tested?
- Cardiac resynchronization therapy pacemaker and Dual chamber pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Patients with standard indications to stimulation with a high probability of paced beats according to the clinical evaluation of the investigators:
- First degree AV block (PR ≥ 220 ms) and indication for pacing
- Paroxysmal AV block second degree (Type I and Type II) associated with long-PR (PR ≥ 220 ms)
- Patient must be able to attend all required follow-up visits at the study center.
- LVEF> 35%
Who cannot join
- Patient is less than 18 years of age.
- Patients with a life expectancy less than 12 months
- Indication for CRT in class I and II
- Third-degree AV block
- Patients currently enrolled in other studies / logs
- Patients who are not able to understand and sign an informed consent
- State of current or planned pregnancy within 12 months of enrollment
- Inability to understand and complete the questionnaire QOL
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Sant'Anna
Como, Como, 22100
Gianluca Botto, clinical-realcrt@isis.it
Gianluca Botto
About this study
This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL -CRT study is designed to test the hypothesis that, in patients with atrioventricular block of I degree and standard pacing indications , biventricular pacing is superior to single stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing , as assessed by echocardiography an endpoint defined in terms of maintenance over time of left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV ) .
Read the detailed description
Clinical data suggest that biventricular pacing is able to preserve the myocardial performance more effectively than the right ventricular pacing in patients with atrioventricular block and mild systolic dysfunction . In particular, some studies have shown that medical therapy in these patients could be responsible for an increase in the cumulative percentage of chronic pacing over the 40% threshold , the threshold associated with a higher incidence of atrial fibrillation and hospitalization for heart failure and ventricular arrhythmias . In addition , patients with pre-existing left ventricular dysfunction and indication for pacing standards have improved left ventricular systolic function , exercise capacity and quality of life as a result of biventricular pacing as compared with Right ventricular pacing . These results suggest that biventricular pacing is a feasible option for permanent pacing in patients who have normal systolic function of the left ventricle and that this can be altered from the adverse effects of conventional Right ventricular pacing on systolic function of the left ventricle . This reality has prompted physicians to assess the value and role of cardiac resynchronization therapy (CRT ) in patients with prolonged Atrio-Ventricular (AV) conduction . Note the deleterious effects of chronic stimulation of the right ventricle , the optimal pacing mode should always be considered in these patients at the time of implantation . This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction, by comparing it with the treatment with dual chamber device
- Conditions
- First Degree Atrioventricular Block
- Being tested
- Cardiac resynchronization therapy pacemaker, Dual chamber pacemaker
- Keywords
- Cardiac Resynchronization therapy, Minimized Right ventricular pacing, Prolonged AV conduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy pacemakerDevice
biventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p)
Dual chamber pacemakerDevice
right ventricular stimulation with dual chamber pacemaker
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular stimulation | Active comparator | patients with conventional Right Ventricular Stimulation (only RV) with optimized algorithms for minimization of pacing Receives: Device: Dual chamber pacemaker |
| Biventricular Stimulation | Experimental | Patients with biventricular stimulation (Right Ventricle and Left Ventricle) Receives: Device: Cardiac resynchronization therapy pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF
LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle)
Measured: 2 years
LVESV
LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling)
Measured: 2 years
Secondary outcomes (4)
echocardiographic left ventricular measures
. Structure and cardiac function:
- Left ventricular End Systolic Diameter, Left ventricular End Diastolic Diameter
- Left Ventricular End Systolic
Measured: 2 years
Echocardiographic altrial measures
Size of the left atrium (diameter and volume)
Measured: 2 years
Clinical outcome
Clinical benefit:
- 6 minute walking test
- quality of life questionnaire
- New York Heart Association class
- number and duration of hospitalizations
Measured: 2 years
Atrial fibrillation (AF)
Incidence of AF:
- incidence of persistent AF
- burden of FA
- new onset of AF
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Degree Atrioventricular BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gianluca Botto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gianluca Botto, S. Anna Hospital
- Investigators
- Gianluca Botto, Principal investigator, S. Anna Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150538
- Sponsor's protocol ID
- Parere Unico 86/13
- Acronym
- REAL-CRT
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Botto GL, Iuliano A, Occhetta E, Belotti G, Russo G, Campari M, Valsecchi S, Stabile G. A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study. Europace. 2020 Feb 1;22(2):299-305. doi: 10.1093/europace/euz321.
PubMed 31722381
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT Study
- ClinicalTrials.gov ID
- NCT02150538
- Acronym / sponsor ID
- REAL-CRT / Parere Unico 86/13
- Conditions
- First Degree Atrioventricular Block
- Keywords
- Cardiac Resynchronization therapy, Minimized Right ventricular pacing, Prolonged AV conduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Gianluca BottoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 May 2014 (estimated)
- 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.
This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction , by comparing the treatment with dual-chamber device . The REAL -CRT study is designed to test the hypothesis that, in patients with atrioventricular block of I degree and standard pacing indications , biventricular pacing is superior to single stimulation of the right ventricle (RV) with optimized algorithms for minimization of pacing , as assessed by echocardiography an endpoint defined in terms of maintenance over time of left ventricular ejection fraction (LVEF ) and left ventricular end-systolic volume ( LVESV ) .
Detailed description
Clinical data suggest that biventricular pacing is able to preserve the myocardial performance more effectively than the right ventricular pacing in patients with atrioventricular block and mild systolic dysfunction . In particular, some studies have shown that medical therapy in these patients could be responsible for an increase in the cumulative percentage of chronic pacing over the 40% threshold , the threshold associated with a higher incidence of atrial fibrillation and hospitalization for heart failure and ventricular arrhythmias . In addition , patients with pre-existing left ventricular dysfunction and indication for pacing standards have improved left ventricular systolic function , exercise capacity and quality of life as a result of biventricular pacing as compared with Right ventricular pacing . These results suggest that biventricular pacing is a feasible option for permanent pacing in patients who have normal systolic function of the left ventricle and that this can be altered from the adverse effects of conventional Right ventricular pacing on systolic function of the left ventricle . This reality has prompted physicians to assess the value and role of cardiac resynchronization therapy (CRT ) in patients with prolonged Atrio-Ventricular (AV) conduction . Note the deleterious effects of chronic stimulation of the right ventricle , the optimal pacing mode should always be considered in these patients at the time of implantation . This study was designed to evaluate the potential benefits of treatment with biventricular device in patients with normal systolic function , indication for pacing and impaired atrio-ventricular conduction, by comparing it with the treatment with dual chamber device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular stimulation | Active comparator | Device: Dual chamber pacemakerpatients with conventional Right Ventricular Stimulation (only RV) with optimized algorithms for minimization of pacing |
| Biventricular Stimulation | Experimental | Device: Cardiac resynchronization therapy pacemakerPatients with biventricular stimulation (Right Ventricle and Left Ventricle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with standard indications to stimulation with a high probability of paced beats according to the clinical evaluation of the investigators:
- First degree AV block (PR ≥ 220 ms) and indication for pacing
- Paroxysmal AV block second degree (Type I and Type II) associated with long-PR (PR ≥ 220 ms)
- Patient must be able to attend all required follow-up visits at the study center.
- LVEF> 35%
Key exclusion criteria (8 listed)
- Patient is less than 18 years of age.
- Patients with a life expectancy less than 12 months
- Indication for CRT in class I and II
- Third-degree AV block
- Patients currently enrolled in other studies / logs
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 |
|---|---|---|
| Cardiac resynchronization therapy pacemakerbiventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p) | Device | Biventricular Stimulation |
| Dual chamber pacemakerright ventricular stimulation with dual chamber pacemaker | Device | Right ventricular stimulation |
Primary outcome
LVEF
Time frame: 2 years
LVEF (Left Ventricular Ejection Fraction: such as the assessment of systolic function of the left ventricle)
LVESV
Time frame: 2 years
LVESV (Left Ventricular End Systolic Volume: such as the assessment of left ventricular remodeling)
4 secondary outcomes
echocardiographic left ventricular measures
Time frame: 2 years
Echocardiographic altrial measures
Time frame: 2 years
Clinical outcome
Time frame: 2 years
Atrial fibrillation (AF)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 31722381Botto GL, Iuliano A, Occhetta E, Belotti G, Russo G, Campari M, Valsecchi S, Stabile G. A randomized controlled trial of cardiac resynchronization therapy in patients with prolonged atrioventricular interval: the REAL-CRT pilot study. Europace. 2020 Feb 1;22(2):299-305. doi: 10.1093/europace/euz321.
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.
Gianluca Botto principal investigator
S. Anna Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy pacemaker and Dual chamber pacemaker in people with First Degree Atrioventricular Block, run by Gianluca Botto 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 5 inclusion and 8 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 21 Apr 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150538, which also lists 1 linked publication.
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 21 Apr 2016.