Quality of LifeCBRAVONCT01998256
Clinical Benefit of Rigourous AV Delay Optimization in Patients With a Dual Chamber Pacemaker
A study testing AV optimization in people with Quality of Life and Pacemaker Ddd Permanent, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Pacemaker Ddd Permanent, Atrial Dysfunction
- What is being tested?
- AV optimization
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Jun 2014
- 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
- Ambulatory all comer patient population at least 3 months after implantation of a dual chamber pacemaker
- Programmed in a DDD(R) modus
- Right ventricular pacing percentage of > 50%
Who cannot join
- permanent atrial fibrillation
- endstage chronic obstructive lung disease
- severe psychiatric, orthopedic or neurological comorbidity
- acute illness at the moment of inclusion
- changes in cardiovascular medication the month before inclusion until the end of the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Patient Blinded, Cross-over Study of the Effect on Clinical Outcomes of AV Optimization in All Comer Ambulatory Patients With a Dual Chamber Pacemaker - The Role of Atrial Function and Interatrial Conduction Delay
Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a possible hemodynamic benefit of this non invasive intervention.
Read the detailed description
Given the high prevalence of interatrial block (WHO definition: PWD on surface ECG > 110 ms) in a general hospitalized population and especially in patient groups with tachyarrhythmias (18% and 52 % respectively), this phenomenon will be important to recognize in a BIC pacemaker patient population. Actually, the prevalence of advanced interatrial block (PWD > 120 ms with biphasic P wave morphology) is 10% in candidates for definitive pacing and 32 % in patients with a bradycardia-tachycardia syndrome. The main underlying mechanism is thought to lie in abnormalities of the Bachmann bundle resulting in partial or advanced interatrial conduction delay (IACD). A normal IACD varies between 60 and 85 ms. Two potential mechanisms are spatial dispersion of refractory periods or anisotropy resulting from scarce side-to-side electrical coupling and fibrosis disrupting the arrangement of atrial muscle fibers.
Patients with an interatrial conduction delay may have a suboptimal left atrioventricular timing due to delayed contraction of the left atrium with foreshortening of ventricular filling. This may be an issue in pacemaker patients, with our without a substrate for heart failure. Beside the loss of reduction of left atrial contraction, it might even induce neurohormonal changes due to atrial stretch and pressure thus lowering blood pressure. Coronary sinus or multisite atrial pacing, both with the aim of synchronizing right and left atrial electrical activation, have shown to (i) improve hemodynamics in patients with an important IACD, both invasively and noninvasively, and to (ii) decrease recurrences of atrial fibrillation. In patients with a conventional BIC pacemaker, prevention of left atrioventricular asynchrony can be achieved by AV optimization (lengthening of the AV delay in case of too short nominal settings) as an alternative. Though all these interventions have proven to have positive hemodynamic results until now evidence about positive effects on clinical patient outcomes are lacking.
On the other hand, some of the patients implanted with a bicameral pacemaker have a too long AV delay. As a consequence diastolic filling time is impaired. Without compromising left atrioventricular synchrony AV delay, optimal AVD (AVO) can be achieved by lengthening of the AVD with conventional methods.
In contrast to the setting of CRT, AV optimization in patients with a bicameral (BIC) pacemaker is not fully implemented in daily clinical practice. Given the proven effect on mitral inflow on echocardiography, we wanted to evaluate the effect of this non invasive intervention on patient functionality and quality of life, based on a comprehensive assessment of atrial pathophysiology.
- Conditions
- Quality of Life, Pacemaker Ddd Permanent, Atrial Dysfunction
- Being tested
- AV optimization
- Keywords
- AV optimization, Interatrial conduction delay
- Medical subject headings
- Interatrial Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV optimizationDevice
Iterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Sham comparator | All patients were programmed in the same nominal AV delay settings (sensed AV delay 120ms, paced AV delay 150 ms) before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field. Receives: Device: AV optimization |
| Group II | Active comparator | All patients were programmed in the same nominal AV delay settings before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field. Receives: Device: AV optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise capacity, expressed by oxygen uptake efficiency slope
Ergospirometry protocol:
Symptom-limited exercise testing was performed on an electronically braked cycle ergometer (eBike 1.8, GE (General Electric) Healthcare) in a non-fasting condition and under medication. All exercise tests took place at a standardized time for each patient. After 1minute (min) of rest followed by 1min of unloaded cycling, the initial load was set at 20W (Watt) for 1 min, and was increased by 10 or 20W every 2 min until exhaustion. Cycle load increments were based on previous exercise testing, aiming to yield a test duration of approximately 10min. All tests were continued to volitional fatigue and no patients were limited by angina. The recovery period lasted at least 2 minutes. A 12-lead electrocardiogram was monitored continuously (Cardiosoft 6.6); maximum heart rate was registered.
The oxygen uptake efficiency slope (OUES) was calculated using [VO2= m(log10VE)+b, where m= OUES]. VO2=oxygen consumption
Measured: baseline, 4 weeks, 8 weeks
Secondary outcomes (9)
Change in exercise capacity, expressed by VO2max (maximal oxygen consumption)
cf. Ergospirometry protocol
Measured: baseline, 4 weeks, 8 weeks
Change in NYHA class: New York Heart Association Class
Measured: baseline, 4 weeks, 8 weeks
Change in quality of life
Quality of life, measured by a standardized Heart Qol questionnaire
Measured: baseline, 4 weeks, 8 weeks
Change in 6-Minute Walk test Distance (6MWD)
Measured: baseline, 4 weeks, 8 weeks
Change in serum brain natriuretic peptide (BNP)
Measured: 4 weeks, 8 weeks
Change in left atrial function, measured by left mitral annular late diastolic peak velocity (A'm(c))
Measured: baseline, 4 weeks, 8 weeks
Change in left atrial function, measured by left atrial late diastolic peak strain (εm)
Measured: baseline, 4 weeks, 8 weeks
Change in left atrial function, measured by left atrial late diastolic peak strain rate (SRm)
Measured: baseline, 4 weeks, 8 weeks
Change in systolic pulmonary artery pressure (PAPs)
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thijs Cools, Jessa Hospital
- Investigators
- Thijs Cools, MD, Principal investigator, Jessa HospitalPaul Dendale, MD, PhD, Study director, Jessa HospitalLieven Herbots, MD, PhD, Study chair, Jessa HospitalRob Geukens, MD, Study chair, Jessa HospitalJan Verwerft, MD, Study chair, Jessa HospitalTara Daerden, Study chair, University HasseltDominique Hansen, PhD, Study chair, University Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998256
- Sponsor's protocol ID
- not yet available
- Acronym
- CBRAVO
- Status last verified
- Sep 2015
- First submitted
- 19 Nov 2013
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ariyarajah V, Spodick DH. Progression of partial to advanced interatrial block. J Electrocardiol. 2006 Apr;39(2):177-9. doi: 10.1016/j.jelectrocard.2005.08.016. Epub 2005 Nov 10.
PubMed 16580415Bayes de Luna A, Platonov P, Cosio FG, Cygankiewicz I, Pastore C, Baranowski R, Bayes-Genis A, Guindo J, Vinolas X, Garcia-Niebla J, Barbosa R, Stern S, Spodick D. Interatrial blocks. A separate entity from left atrial enlargement: a consensus report. J Electrocardiol. 2012 Sep;45(5):445-51. doi: 10.1016/j.jelectrocard.2012.06.029.
PubMed 22920783Bayés de Luna A. Electrocardiographic alterations due to atrial pathology. Clinical Electrocardiography: A Text Book. New York: Futura Company; 1998: p69.
Daubert JC, Pavin D, Jauvert G, Mabo P. Intra- and interatrial conduction delay: implications for cardiac pacing. Pacing Clin Electrophysiol. 2004 Apr;27(4):507-25. doi: 10.1111/j.1540-8159.2004.00473.x.
PubMed 15078407Burri H, Bennani I, Domenichini G, Ganiere V, Sunthorn H, Stettler C, Gentil P, Shah D. Biatrial pacing improves atrial haemodynamics and atrioventricular timing compared with pacing from the right atrial appendage. Europace. 2011 Sep;13(9):1262-7. doi: 10.1093/europace/eur099. Epub 2011 Apr 6.
PubMed 21474460Doi A, Takagi M, Toda I, Yoshiyama M, Takeuchi K, Yoshikawa J. Acute hemodynamic benefits of bi-atrial atrioventricular sequential pacing with the optimal atrioventricular delay. J Am Coll Cardiol. 2005 Jul 19;46(2):320-6. doi: 10.1016/j.jacc.2005.04.032.
PubMed 16022962Verlato R, Botto GL, Massa R, Amellone C, Perucca A, Bongiorni MG, Bertaglia E, Ziacchi V, Piacenti M, Del Rosso A, Russo G, Baccillieri MS, Turrini P, Corbucci G. Efficacy of low interatrial septum and right atrial appendage pacing for prevention of permanent atrial fibrillation in patients with sinus node disease: results from the electrophysiology-guided pacing site selection (EPASS) study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):844-50. doi: 10.1161/CIRCEP.110.957126. Epub 2011 Sep 23.
PubMed 21946316Kindermann M, Frohlig G, Doerr T, Schieffer H. Optimizing the AV delay in DDD pacemaker patients with high degree AV block: mitral valve Doppler versus impedance cardiography. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2453-62. doi: 10.1111/j.1540-8159.1997.tb06085.x.
PubMed 9358487Antonini L, Auriti A, Pasceri V, Meo A, Pristipino C, Varveri A, Greco S, Santini M. Optimization of the atrioventricular delay in sequential and biventricular pacing: physiological bases, critical review, and new purposes. Europace. 2012 Jul;14(7):929-38. doi: 10.1093/europace/eur425. Epub 2012 Feb 6.
PubMed 22310153Barold SS, Ilercil A, Herweg B. Echocardiographic optimization of the atrioventricular and interventricular intervals during cardiac resynchronization. Europace. 2008 Nov;10 Suppl 3:iii88-95. doi: 10.1093/europace/eun220.
PubMed 18955406Bowen TS, Cannon DT, Begg G, Baliga V, Witte KK, Rossiter HB. A novel cardiopulmonary exercise test protocol and criterion to determine maximal oxygen uptake in chronic heart failure. J Appl Physiol (1985). 2012 Aug;113(3):451-8. doi: 10.1152/japplphysiol.01416.2011. Epub 2012 May 31.
PubMed 22653993Laurent G, Eicher JC, Mathe A, Bertaux G, Barthez O, Debin R, Billard C, Philip JL, Wolf JE. Permanent left atrial pacing therapy may improve symptoms in heart failure patients with preserved ejection fraction and atrial dyssynchrony: a pilot study prior to a national clinical research programme. Eur J Heart Fail. 2013 Jan;15(1):85-93. doi: 10.1093/eurjhf/hfs150. Epub 2012 Sep 27.
PubMed 23018991Yasuoka Y, Abe H, Umekawa S, Katsuki K, Tanaka N, Araki R, Imanaka T, Matsutera R, Morisawa D, Kitada H, Hattori S, Noda Y, Adachi H, Sasaki T, Miyatake K. Interatrial septum pacing decreases atrial dyssynchrony on strain rate imaging compared with right atrial appendage pacing. Pacing Clin Electrophysiol. 2011 Mar;34(3):370-6. doi: 10.1111/j.1540-8159.2010.02976.x. Epub 2010 Nov 22.
PubMed 21091742Sirbu C, Herbots L, D'hooge J, Claus P, Marciniak A, Langeland T, Bijnens B, Rademakers FE, Sutherland GR. Feasibility of strain and strain rate imaging for the assessment of regional left atrial deformation: a study in normal subjects. Eur J Echocardiogr. 2006 Jun;7(3):199-208. doi: 10.1016/j.euje.2005.06.001. Epub 2005 Jul 28.
PubMed 16054869Van Beeumen K, Duytschaever M, Tavernier R, Van de Veire N, De Sutter J. Intra- and interatrial asynchrony in patients with heart failure. Am J Cardiol. 2007 Jan 1;99(1):79-83. doi: 10.1016/j.amjcard.2006.07.066. Epub 2006 Nov 9.
PubMed 17196467
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Patient Blinded, Cross-over Study of the Effect on Clinical Outcomes of AV Optimization in All Comer Ambulatory Patients With a Dual Chamber Pacemaker - The Role of Atrial Function and Interatrial Conduction Delay
- ClinicalTrials.gov ID
- NCT01998256
- Acronym / sponsor ID
- CBRAVO / not yet available
- Conditions
- Quality of Life, Pacemaker Ddd Permanent, Atrial Dysfunction
- Keywords
- AV optimization, Interatrial conduction delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Nov 2013 (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.
Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a possible hemodynamic benefit of this non invasive intervention.
Detailed description
Given the high prevalence of interatrial block (WHO definition: PWD on surface ECG > 110 ms) in a general hospitalized population and especially in patient groups with tachyarrhythmias (18% and 52 % respectively), this phenomenon will be important to recognize in a BIC pacemaker patient population. Actually, the prevalence of advanced interatrial block (PWD > 120 ms with biphasic P wave morphology) is 10% in candidates for definitive pacing and 32 % in patients with a bradycardia-tachycardia syndrome. The main underlying mechanism is thought to lie in abnormalities of the Bachmann bundle resulting in partial or advanced interatrial conduction delay (IACD). A normal IACD varies between 60 and 85 ms. Two potential mechanisms are spatial dispersion of refractory periods or anisotropy resulting from scarce side-to-side electrical coupling and fibrosis disrupting the arrangement of atrial muscle fibers.
Patients with an interatrial conduction delay may have a suboptimal left atrioventricular timing due to delayed contraction of the left atrium with foreshortening of ventricular filling. This may be an issue in pacemaker patients, with our without a substrate for heart failure. Beside the loss of reduction of left atrial contraction, it might even induce neurohormonal changes due to atrial stretch and pressure thus lowering blood pressure. Coronary sinus or multisite atrial pacing, both with the aim of synchronizing right and left atrial electrical activation, have shown to (i) improve hemodynamics in patients with an important IACD, both invasively and noninvasively, and to (ii) decrease recurrences of atrial fibrillation. In patients with a conventional BIC pacemaker, prevention of left atrioventricular asynchrony can be achieved by AV optimization (lengthening of the AV delay in case of too short nominal settings) as an alternative. Though all these interventions have proven to have positive hemodynamic results until now evidence about positive effects on clinical patient outcomes are lacking.
On the other hand, some of the patients implanted with a bicameral pacemaker have a too long AV delay. As a consequence diastolic filling time is impaired. Without compromising left atrioventricular synchrony AV delay, optimal AVD (AVO) can be achieved by lengthening of the AVD with conventional methods.
In contrast to the setting of CRT, AV optimization in patients with a bicameral (BIC) pacemaker is not fully implemented in daily clinical practice. Given the proven effect on mitral inflow on echocardiography, we wanted to evaluate the effect of this non invasive intervention on patient functionality and quality of life, based on a comprehensive assessment of atrial pathophysiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Sham comparator | Device: AV optimizationAll patients were programmed in the same nominal AV delay settings (sensed AV delay 120ms, paced AV delay 150 ms) before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field. |
| Group II | Active comparator | Device: AV optimizationAll patients were programmed in the same nominal AV delay settings before randomization. Patients in group I received a sham AV optimization; patients in group II received a real AV optimization. Baseline echocardiography measurements were repeated after (sham)optimization. At 4 weeks cross-over was done by AV optimization in group I and resetting pacemaker settings to nominal values in group II. At 8 weeks patients were evaluated with the same investigations as at week 4; every pacemaker was programmed in the most optimal AV setting. All optimizations were performed by 2 unblinded echocardiographists with experience in the field. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory all comer patient population at least 3 months after implantation of a dual chamber pacemaker
- Programmed in a DDD(R) modus
- Right ventricular pacing percentage of > 50%
Key exclusion criteria (5 listed)
- permanent atrial fibrillation
- endstage chronic obstructive lung disease
- severe psychiatric, orthopedic or neurological comorbidity
- acute illness at the moment of inclusion
- changes in cardiovascular medication the month before inclusion until the end of the study protocol
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 |
|---|---|---|
| AV optimizationIterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements. | Device | Group I, Group II |
Primary outcome
Change in exercise capacity, expressed by oxygen uptake efficiency slope
Time frame: baseline, 4 weeks, 8 weeks
Ergospirometry protocol: Symptom-limited exercise testing was performed on an electronically braked cycle ergometer (eBike 1.8, GE (General Electric) Healthcare) in a non-fasting condition and under medication. All exercise tests took place at a standardized time for each patient. After 1minute (min) of rest followed by 1min of unloaded cycling, the initial load was set at 20W (Watt) for 1 min, and was increased by 10 or 20W every 2 min until exhaustion. Cycle load increments were based on previous exercise testing, aiming to yield a test duration of approximately 10min. All tests were continued to volitional fatigue and no patients were limited by angina. The recovery period lasted at least 2 minutes. A 12-lead electrocardiogram was monitored continuously (Cardiosoft 6.6); maximum heart rate was registered. The oxygen uptake efficiency slope (OUES) was calculated using [VO2= m(log10VE)+b, where m= OUES]. VO2=oxygen consumption
9 secondary outcomes
Change in exercise capacity, expressed by VO2max (maximal oxygen consumption)
Time frame: baseline, 4 weeks, 8 weeks
Change in NYHA class: New York Heart Association Class
Time frame: baseline, 4 weeks, 8 weeks
Change in quality of life
Time frame: baseline, 4 weeks, 8 weeks
Change in 6-Minute Walk test Distance (6MWD)
Time frame: baseline, 4 weeks, 8 weeks
Change in serum brain natriuretic peptide (BNP)
Time frame: 4 weeks, 8 weeks
Change in left atrial function, measured by left mitral annular late diastolic peak velocity (A'm(c))
Time frame: baseline, 4 weeks, 8 weeks
Change in left atrial function, measured by left atrial late diastolic peak strain (εm)
Time frame: baseline, 4 weeks, 8 weeks
Change in left atrial function, measured by left atrial late diastolic peak strain rate (SRm)
Time frame: baseline, 4 weeks, 8 weeks
Change in systolic pulmonary artery pressure (PAPs)
Time frame: baseline, 4 weeks, 8 weeks
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 15 Sep 2015.
- Background: PubMed 16580415Ariyarajah V, Spodick DH. Progression of partial to advanced interatrial block. J Electrocardiol. 2006 Apr;39(2):177-9. doi: 10.1016/j.jelectrocard.2005.08.016. Epub 2005 Nov 10.
- Background: PubMed 22920783Bayes de Luna A, Platonov P, Cosio FG, Cygankiewicz I, Pastore C, Baranowski R, Bayes-Genis A, Guindo J, Vinolas X, Garcia-Niebla J, Barbosa R, Stern S, Spodick D. Interatrial blocks. A separate entity from left atrial enlargement: a consensus report. J Electrocardiol. 2012 Sep;45(5):445-51. doi: 10.1016/j.jelectrocard.2012.06.029.
- BackgroundBayés de Luna A. Electrocardiographic alterations due to atrial pathology. Clinical Electrocardiography: A Text Book. New York: Futura Company; 1998: p69.
- Background: PubMed 15078407Daubert JC, Pavin D, Jauvert G, Mabo P. Intra- and interatrial conduction delay: implications for cardiac pacing. Pacing Clin Electrophysiol. 2004 Apr;27(4):507-25. doi: 10.1111/j.1540-8159.2004.00473.x.
- Background: PubMed 21474460Burri H, Bennani I, Domenichini G, Ganiere V, Sunthorn H, Stettler C, Gentil P, Shah D. Biatrial pacing improves atrial haemodynamics and atrioventricular timing compared with pacing from the right atrial appendage. Europace. 2011 Sep;13(9):1262-7. doi: 10.1093/europace/eur099. Epub 2011 Apr 6.
- Background: PubMed 16022962Doi A, Takagi M, Toda I, Yoshiyama M, Takeuchi K, Yoshikawa J. Acute hemodynamic benefits of bi-atrial atrioventricular sequential pacing with the optimal atrioventricular delay. J Am Coll Cardiol. 2005 Jul 19;46(2):320-6. doi: 10.1016/j.jacc.2005.04.032.
- Background: PubMed 21946316Verlato R, Botto GL, Massa R, Amellone C, Perucca A, Bongiorni MG, Bertaglia E, Ziacchi V, Piacenti M, Del Rosso A, Russo G, Baccillieri MS, Turrini P, Corbucci G. Efficacy of low interatrial septum and right atrial appendage pacing for prevention of permanent atrial fibrillation in patients with sinus node disease: results from the electrophysiology-guided pacing site selection (EPASS) study. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):844-50. doi: 10.1161/CIRCEP.110.957126. Epub 2011 Sep 23.
- Background: PubMed 9358487Kindermann M, Frohlig G, Doerr T, Schieffer H. Optimizing the AV delay in DDD pacemaker patients with high degree AV block: mitral valve Doppler versus impedance cardiography. Pacing Clin Electrophysiol. 1997 Oct;20(10 Pt 1):2453-62. doi: 10.1111/j.1540-8159.1997.tb06085.x.
- Background: PubMed 22310153Antonini L, Auriti A, Pasceri V, Meo A, Pristipino C, Varveri A, Greco S, Santini M. Optimization of the atrioventricular delay in sequential and biventricular pacing: physiological bases, critical review, and new purposes. Europace. 2012 Jul;14(7):929-38. doi: 10.1093/europace/eur425. Epub 2012 Feb 6.
- Background: PubMed 18955406Barold SS, Ilercil A, Herweg B. Echocardiographic optimization of the atrioventricular and interventricular intervals during cardiac resynchronization. Europace. 2008 Nov;10 Suppl 3:iii88-95. doi: 10.1093/europace/eun220.
- Background: PubMed 22653993Bowen TS, Cannon DT, Begg G, Baliga V, Witte KK, Rossiter HB. A novel cardiopulmonary exercise test protocol and criterion to determine maximal oxygen uptake in chronic heart failure. J Appl Physiol (1985). 2012 Aug;113(3):451-8. doi: 10.1152/japplphysiol.01416.2011. Epub 2012 May 31.
- Background: PubMed 23018991Laurent G, Eicher JC, Mathe A, Bertaux G, Barthez O, Debin R, Billard C, Philip JL, Wolf JE. Permanent left atrial pacing therapy may improve symptoms in heart failure patients with preserved ejection fraction and atrial dyssynchrony: a pilot study prior to a national clinical research programme. Eur J Heart Fail. 2013 Jan;15(1):85-93. doi: 10.1093/eurjhf/hfs150. Epub 2012 Sep 27.
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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.
Thijs Cools, MD principal investigator
Jessa Hospital
Paul Dendale, MD, PhD study director
Jessa Hospital
Lieven Herbots, MD, PhD study chair
Jessa 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 AV optimization in people with Quality of Life and Pacemaker Ddd Permanent, run by Jessa Hospital at 1 site in Belgium.
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 3 inclusion and 5 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 15 Sep 2015. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
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?
Change in exercise capacity, expressed by oxygen uptake efficiency slope (time frame: baseline, 4 weeks, 8 weeks). 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 NCT01998256, which also lists 20 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 15 Sep 2015.