Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA GuidelinesPhase 3CAN-SAVE RNCT01219621
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
A Phase 3 study testing Symphony Dual Chamber Rate Responsive Device in people with Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines, run by Sorin Group Canada at 10 sites in Canada.
Trial summary
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
- What is being tested?
- Symphony Dual Chamber Rate Responsive Device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 10 sitesCanada
- Study dates
- Apr 2006to Apr 2009
- Phase
- Phase 3
- 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
- Inclusion criteria / Indications Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation) may be included in the study.
Who cannot join
- The patients presenting with one or more of the following characteristics cannot be included:
- Permanent complete AV block
- Permanent atrial and/or ventricular arrhythmias
- already implanted with a cardioverter-defibrillator (ICD)
- Likely to have a cardiac surgery in the next six months, mainly for:
- severe coronary artery disease
Show all 16Show fewer
- severe valvular disease
- Refuses to sign an consent form after having received the appropriate information
- Refuses to co-operate
- Not able to understand the study objectives and protocol
- Not available for scheduled follow-up
- With a life expectancy less than one year
- Already included into another clinical study competing with the objectives of the CAN-SAVE R study.
- <18 years old.
- Contraindications Any patient to whom a contraindication from device labeling applies shall not be included in the study.
- -
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Grey Nuns hospital
Edmonton, Alberta, T6L 5X8
Royal-Alex hospital
Edmonton, Alberta
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Institute de Cardilogie, Montreal Heart Institute
Montreal, Quebec, H1t 1c8
Southlake hospital
Newmarket, Ontario
Hotel-Dieu St Jerome
Saint-Jérôme, Quebec, J7Z 5T3
SASKATOON hospital
Saskatoon, Saskatchewan
Laval hospital
Ste Foy, Quebec
St Mike's hospital
Toronto, Ontario
Trois-Riviere general hospital
Trois-Rivières, Quebec
About this study
Official title: A Prospective Canadian Multi-Center Randomized Study; Spontaneous AtrioVEntricular Conduction PReservation
1 Purpose
In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. As a result, these patients are usually exposed to an unnecessary high proportion of ventricular pacing due to the programming of the system to DDD mode for preventive safety reasons. This drains the pulse generator battery, and more importantly has long-term adverse effects on ventricular function in a subset of vulnerable patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related adverse events have been highlighted in several large clinical studies. Limiting RV pacing in non-dependant patients is therefore desirable.
Read more
The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).
The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii) prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term hemodynamic status of implanted patients in comparison to the "standard" DDD mode, set with long AV Delays (DDD Long AVD).
The scientific soundness lying in this study is a proposal of an optimal programming of dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.
Read the detailed description
In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. As a result, these patients are usually exposed to an unnecessary high proportion of ventricular pacing due to the programming of the system to DDD mode for preventive safety reasons. This drains the pulse generator battery, and more importantly has long-term adverse effects on ventricular function in a subset of vulnerable patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related adverse events have been highlighted in several large clinical studies. Limiting RV pacing in non-dependant patients is therefore desirable.
The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).
The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii) prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term hemodynamic status of implanted patients in comparison to the "standard" DDD mode, set with long AV Delays (DDD Long AVD).
The scientific soundness lying in this study is a proposal of an optimal programming of dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.
2 Study devices
Classification Name Manufacturer Name Cardiovascular permanent pacemaker pulse generator SORIN Group Symphony ™ DR2550
3 Summary of study objectives
The aims of this study are to assess the clinical benefits resulting from AAIsafeR2 by comparison with standard dual chamber programming (DDD) with a long AV Delay.
The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and ANP/BNP measurements.
The primary objectives of the study are:
to demonstrate the effectiveness of AAIsafeR2 to preserve natural AV conduction as compared to DDD Long AVD. For this purpose, ventricular pacing ratio as retrieved from PM memory will be assessed on a mid-term period (1 year) by inter-groups comparison of:
- Mean V pacing (%)
- Proportion of patients with a V pacing ratio < 1 %. to demonstrate the effectiveness of AAIsafeR2 to reduce AF incidence on a long-term basis (3-year follow-up) by analyzing in the randomized branches:
- the cumulative time in AF (as documented by PM memory)
- the total number of AF episodes (as documented by PM memory)
- the number of patients who present a cumulative time in AF>30% of the follow-up period (as documented by PM memory)
- the proportion of patients who turned into persistent AF during the study.
- the proportion of patients who turned into permanent AF during the study. to compare the effects of AAISafeR2 vs. DDD Long AVD on LV function, mitral regurgitation and LA dimensions on a long-term basis (3-year follow-up) by comparing:
- LV ejection fraction (EF) and volumes
- Left atrium dimensions
- Mitral regurgitation severity as measured by standard echocardiographic methods.
The secondary objectives of this study are to report and compare the following in each randomized arm of the study:
Total mortality CHF-related mortality and hospitalizations Evolution of systemic blood pressures, as estimated by ANP/BNP measurements AF-related adverse events, such as strokes/TIA's and cardioversions The evolution of cardiac asynchrony [inter-ventricular (RV-LV) and intra-ventricular (4 segments), as assessed by TDI technics] The evolution of conduction disturbances in patients presenting unknown or under estimated atrio-ventricular blocks on a long-term basis (intra-group analysis). Stratification by pacing indications and cardiopathies.
- Being tested
- Symphony Dual Chamber Rate Responsive Device
- Keywords
- Symphony DR 2550,, Dual Chamber Pacemaker,, Sorin,, Ela Medical,, DDD Mode,, AAIsafeR2 mode,, AV-Conduction,, Reducing Ventricular Pacing,, Congestive Heart Failure,, Cardiac Function,, Atrial Arrhythmia,, Atrial Fibrillation,, Atrial and Ventricular Hemodynamics,, Long AV-delays., Ventricular Function,, Implantation,
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony Dual Chamber Rate Responsive DeviceProcedure or surgery
Echocardiography ANP/BNP measurements
| Study group | Role | What they receive |
|---|---|---|
| DDD Long AVD | Active comparator | Not described Receives: Procedure: Symphony Dual Chamber Rate Responsive Device |
| safeR | Experimental | Not described Receives: Procedure: Symphony Dual Chamber Rate Responsive Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ventricular pacing
Atrial Fibrillation/Atrial Arrhythmia Evolution
Cardiac Function Evolution
Secondary outcomes (3)
Congestive Hear Failure and Atrial Fibrillation Clinical Events
Evolution of conduction Disturbances
Safety Analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startApr 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA GuidelinesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Group Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard Thibault, MD, IntMed,Cardiologist, Principal investigator, Institute de Cardilogie Montreal, Montreal Hear t Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219621
- Sponsor's protocol ID
- IGXD04
- Acronym
- CAN-SAVE R
- Status last verified
- Sep 2006
- First submitted
- 12 Oct 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Thibault B, Simpson C, Gagne CE, Blier L, Senaratne M, McNicoll S, Stuglin C, Williams R, Pinter A, Khaykin Y, Nitzsche R. Impact of AV conduction disorders on SafeR mode performance. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S231-5. doi: 10.1111/j.1540-8159.2008.02293.x.
PubMed 19250103Thibault B, Ducharme A, Baranchuk A, Dubuc M, Dyrda K, Guerra PG, Macle L, Mondesert B, Rivard L, Roy D, Talajic M, Andrade J, Nitzsche R, Khairy P; CAN-SAVE R Study Investigators. Very Low Ventricular Pacing Rates Can Be Achieved Safely in a Heterogeneous Pacemaker Population and Provide Clinical Benefits: The CANadian Multi-Centre Randomised Study-Spontaneous AtrioVEntricular Conduction pReservation (CAN-SAVE R) Trial. J Am Heart Assoc. 2015 Jul 23;4(7):e001983. doi: 10.1161/JAHA.115.001983.
PubMed 26206737
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Canadian Multi-Center Randomized Study; Spontaneous AtrioVEntricular Conduction PReservation
- ClinicalTrials.gov ID
- NCT01219621
- Acronym / sponsor ID
- CAN-SAVE R / IGXD04
- Keywords
- Symphony DR 2550,, Dual Chamber Pacemaker,, Sorin,, Ela Medical,, DDD Mode,, AAIsafeR2 mode,, AV-Conduction,, Reducing Ventricular Pacing,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sorin Group CanadaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Oct 2010 (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.
1 Purpose
In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. As a result, these patients are usually exposed to an unnecessary high proportion of ventricular pacing due to the programming of the system to DDD mode for preventive safety reasons. This drains the pulse generator battery, and more importantly has long-term adverse effects on ventricular function in a subset of vulnerable patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related adverse events have been highlighted in several large clinical studies. Limiting RV pacing in non-dependant patients is therefore desirable.
The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).
The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii) prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term hemodynamic status of implanted patients in comparison to the "standard" DDD mode, set with long AV Delays (DDD Long AVD).
The scientific soundness lying in this study is a proposal of an optimal programming of dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.
Detailed description
In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers are contraindicated although ventricular support is only rarely needed. As a result, these patients are usually exposed to an unnecessary high proportion of ventricular pacing due to the programming of the system to DDD mode for preventive safety reasons. This drains the pulse generator battery, and more importantly has long-term adverse effects on ventricular function in a subset of vulnerable patients, leading to left ventricular (LV) asynchrony, mitral regurgitation and increased left atrium (LA) size. The deleterious effects of right ventricular (RV) pacing, which increased heart failure (HF) morbidity/mortality, atrial fibrillation (AF) and related adverse events have been highlighted in several large clinical studies. Limiting RV pacing in non-dependant patients is therefore desirable.
The Symphony DR 2550 cardiac pacemakers (SORIN Group, Montrouge, France) offer a new pacing mode that automatically switches from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. This particular mode is called the AAIsafeR2(R).
The objective of this study is three-fold: to demonstrate that AAIsafeR2 mode (i) reduces the percentage of ventricular pacing in patients with a spontaneous AV conduction and (ii) prevents atrial arrhythmias by improving atrial hemodynamics and (iii) improves the long-term hemodynamic status of implanted patients in comparison to the "standard" DDD mode, set with long AV Delays (DDD Long AVD).
The scientific soundness lying in this study is a proposal of an optimal programming of dual-chamber pacemakers (PM) with regard to the preservation of spontaneous AV conduction.
2 Study devices
Classification Name Manufacturer Name Cardiovascular permanent pacemaker pulse generator SORIN Group Symphony ™ DR2550
3 Summary of study objectives
The aims of this study are to assess the clinical benefits resulting from AAIsafeR2 by comparison with standard dual chamber programming (DDD) with a long AV Delay.
The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and ANP/BNP measurements.
The primary objectives of the study are:
to demonstrate the effectiveness of AAIsafeR2 to preserve natural AV conduction as compared to DDD Long AVD. For this purpose, ventricular pacing ratio as retrieved from PM memory will be assessed on a mid-term period (1 year) by inter-groups comparison of:
- Mean V pacing (%)
- Proportion of patients with a V pacing ratio < 1 %. to demonstrate the effectiveness of AAIsafeR2 to reduce AF incidence on a long-term basis (3-year follow-up) by analyzing in the randomized branches:
- the cumulative time in AF (as documented by PM memory)
- the total number of AF episodes (as documented by PM memory)
- the number of patients who present a cumulative time in AF>30% of the follow-up period (as documented by PM memory)
- the proportion of patients who turned into persistent AF during the study.
- the proportion of patients who turned into permanent AF during the study. to compare the effects of AAISafeR2 vs. DDD Long AVD on LV function, mitral regurgitation and LA dimensions on a long-term basis (3-year follow-up) by comparing:
- LV ejection fraction (EF) and volumes
- Left atrium dimensions
- Mitral regurgitation severity as measured by standard echocardiographic methods.
The secondary objectives of this study are to report and compare the following in each randomized arm of the study:
Total mortality CHF-related mortality and hospitalizations Evolution of systemic blood pressures, as estimated by ANP/BNP measurements AF-related adverse events, such as strokes/TIA's and cardioversions The evolution of cardiac asynchrony [inter-ventricular (RV-LV) and intra-ventricular (4 segments), as assessed by TDI technics] The evolution of conduction disturbances in patients presenting unknown or under estimated atrio-ventricular blocks on a long-term basis (intra-group analysis). Stratification by pacing indications and cardiopathies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDD Long AVD | Active comparator | Procedure: Symphony Dual Chamber Rate Responsive Device |
| safeR | Experimental | Procedure: Symphony Dual Chamber Rate Responsive Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria / Indications Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation) may be included in the study.
Key exclusion criteria (16 listed)
- The patients presenting with one or more of the following characteristics cannot be included:
- Permanent complete AV block
- Permanent atrial and/or ventricular arrhythmias
- already implanted with a cardioverter-defibrillator (ICD)
- Likely to have a cardiac surgery in the next six months, mainly for:
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 |
|---|---|---|
| Symphony Dual Chamber Rate Responsive DeviceEchocardiography ANP/BNP measurements | Procedure or surgery | DDD Long AVD, safeR |
Primary outcome
Percentage of ventricular pacing
Atrial Fibrillation/Atrial Arrhythmia Evolution
Cardiac Function Evolution
3 secondary outcomes
Congestive Hear Failure and Atrial Fibrillation Clinical Events
Evolution of conduction Disturbances
Safety Analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Results publication: PubMed 19250103Thibault B, Simpson C, Gagne CE, Blier L, Senaratne M, McNicoll S, Stuglin C, Williams R, Pinter A, Khaykin Y, Nitzsche R. Impact of AV conduction disorders on SafeR mode performance. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S231-5. doi: 10.1111/j.1540-8159.2008.02293.x.
- Derived from this study: PubMed 26206737Thibault B, Ducharme A, Baranchuk A, Dubuc M, Dyrda K, Guerra PG, Macle L, Mondesert B, Rivard L, Roy D, Talajic M, Andrade J, Nitzsche R, Khairy P; CAN-SAVE R Study Investigators. Very Low Ventricular Pacing Rates Can Be Achieved Safely in a Heterogeneous Pacemaker Population and Provide Clinical Benefits: The CANadian Multi-Centre Randomised Study-Spontaneous AtrioVEntricular Conduction pReservation (CAN-SAVE R) Trial. J Am Heart Assoc. 2015 Jul 23;4(7):e001983. doi: 10.1161/JAHA.115.001983.
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.
Bernard Thibault, MD, IntMed,Cardiologist principal investigator
Institute de Cardilogie Montreal, Montreal Hear t Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symphony Dual Chamber Rate Responsive Device in people with Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines, run by Sorin Group Canada at 10 sites in Canada.
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 1 inclusion and 16 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: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of ventricular pacing. The study lists 3 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 NCT01219621, which also lists 2 linked publications.
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 13 Oct 2010.