Sick Sinus SyndromeVOTENCT01477138
RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome
An observational study of Sick Sinus Syndrome, run by Klinikum Nürnberg at 1 site in Germany.
Trial summary
Background: Potential negative effects of pacing in the RV-apex are well documented However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial. The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sick Sinus Syndrome
- What is being tested?
- pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Dec 2013
- 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: Adults with symptomathic sick sinus syndrome
Who may be able to join
- Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Who cannot join
- Life expectancy <2 years
- Age < 18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
- Permanent atrial fibrillation
Show all 11Show fewer
- Heart failure NYHA III and IV, reduced LV-EF < 40%
- ICD indication
- Acute coronary syndrome. PCI or CABG < 3 months
- Heart transplant
- Placement of septal RV electrode is not possible
Trial locations and contacts
1 site in 1 country.
Natalia Rohr contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum Nuernberg South
Nuremberg, Bavaria, 90471
Bastian, dirk.bastian@klinikum-nuernberg.de
Natalia Rohr
About this study
Official title: Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome
Background:
- Potential negative effects of pacing in the RV-apex are well documented
- However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial.
- The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial [DANPACE, ESC 2010, Stockholm].
Read more
Aim:
- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS
Inclusion criterion:
-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Exclusion criteria:
- Life expectancy < 2 years
- Age <18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
- Permanent atrial fibrillation
- Heart failure NYHA III and IV, reduced LV-EF <40%
- ICD indication
- Acute coronary syndrome. PCI or CABG <3 months
- Heart transplant
- Placement of septal RV electrode is not possible
Study design:
- Prospective, monocentric, randomized, double-blinded
- Run-in phase: for weeks AAI [R]-DDD [R]
- Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].
- FU: 6 and 12-months
Primary endpoints:
-LV ejection fraction and end-systolic LV volume after 12 months.
Secondary endpoints:
-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.
Statistics/sample size estimation:
In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:
- 90% power/alpha 5%: 84 patients per group
- 80% power/alpha 5%: 63 patients per group
- 10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.
Material
- PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)
- pacing leads: market-released standard active electrodes
- RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
Read the detailed description
Background:
- Potential negative effects of pacing in the RV-apex are well documented
- Asynchronous ventricular activation
- reduction of systolic and diastolic LV function
- Experimental data: histological changes
- Asymmetric LV hypertrophy and thinning
- However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial:
- Acute versus chronic
- Small number of cases, uncontrolled, unblinded,
- Brief periods of observation in the cross-over design (3 months)
- "RVOT" often summarizes different stimulation sites: high RVOT, lateral, septal. Actually only limited data with proven septal stimulation
- No objective performance assessment (CPX)
- Assessment of alternative stimulation site previously RVOT versus RV-apex,
- ventricular pacing compared to ventricular pacing, then tested a potential harm to another
- The question of the optimal pacing mode of patients with SSS (DDDR versus AAIR) appears to be open again. While in Germany, two-chamber systems with AAI [R] mode with ventricular back-up are used, should the DDD (R) mode with an AV delay ≤ 220 ms be the preferred pacing mode, according to the results of the DANPACE trial for patients with SSS [DANPACE, ESC 2010, Stockholm].
Aim:
- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS
Inclusion criterion:
-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Exclusion criteria:
- Life expectancy < 2 years
- Age <18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
- Permanent atrial fibrillation
- Heart failure NYHA III and IV, reduced LV-EF <40%
- ICD indication
- Acute coronary syndrome. PCI or CABG <3 months
- Heart transplant
- Placement of septal RV electrode is not possible
Study design:
- Prospective, monocentric, randomized, double-blinded
- Run-in phase: 4 weeks AAI [R]-DDD [R]
- ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire
- Randomization: two groups 4 weeks (between 3 to 6 weeks) after implant A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].
- FU: 6 and 12-months
- ECG, Holter-ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire
- Extension of follow-up if possible
Primary endpoints:
-LV ejection fraction and end-systolic LV volume after 12 months.
Secondary endpoints:
-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.
Blinding:
- Patient compared to the pacing mode
- Physician: offline analysis of echo and CPX blinded to the pacing mode
Statistics/sample size estimation:
In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:
- 90% power/alpha 5%: 84 patients per group
- 80% power/alpha 5%: 63 patients per group
- 10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.
Material
- PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)
- pacing leads: market-released standard active electrodes (eg. BSCI FineLine 4470 and 4471) Implantation
- Transvenously
- RA-electrode: if possible, short atrial conduction time
- RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
- Conditions
- Sick Sinus Syndrome
- Being tested
- pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)
- Keywords
- Sick Sinus Syndrome, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy, Pacemaker, Artificial, SSS
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)Procedure or surgery
Also called AAI(R)<=>DDD(R), DDD(R)
Indication for pacemaker implantation: sick sinus syndrome in conformity with the current guidelines. Only market-released CE certified 2-chamber cardiac pacemakers and electrodes are used. The implantation is done according to the applicable standards. Active RV-lead is positioned on the right ventricular septum.
| Study group | Role | What they receive |
|---|---|---|
| DDD(R) | SSS. PM programmed to DDD(R) mode with ventricular pacing on the right ventricular septum. Receives: Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R) | |
| AAI(R)<=>DDD(R) | SSS, PM-mode programmed for minimizing right ventricular pacing on the right interventricular septum Receives: Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
end-systolic LV volume
Measured: at randomisation and after 12 months
left ventricular ejection fraction (LV-EF)
TTE, Simpson, biplane
Measured: at randomisation and after 12 months
Secondary outcomes (7)
TAPSE
Measured: at randomisation and after 12 months
echocardiographic parameter of dyssynchrony
TTE, SPWMD, LV-PEP, IVMD
Measured: at randomisation and after 12 months
peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope
CPX: cardiopulmonary exercice testing
Measured: at randomisation and after 12 months
quality of life-scores
SF-36
Measured: at randomisation and after 12 months
AF burden
Measured: at randomisation and after 12 months
% ventricular pacing
Measured: at randomisation and after 12 months
LV end diastolic volume
TTE
Measured: at randomisation and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Rohr, Klinikum Nürnberg
- Investigators
- Matthias Pauschinger, Prof.Dr.med., Study chair, Klinikum Nuernberg South/ CardiologyDirk Bastian, MD, Principal investigator, Klinikum Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477138
- Sponsor's protocol ID
- VOTEPM
- Acronym
- VOTE
- Status last verified
- Nov 2011
- First submitted
- 5 Jul 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwaab B, Frohlig G, Alexander C, Kindermann M, Hellwig N, Schwerdt H, Kirsch CM, Schieffer H. Influence of right ventricular stimulation site on left ventricular function in atrial synchronous ventricular pacing. J Am Coll Cardiol. 1999 Feb;33(2):317-23. doi: 10.1016/s0735-1097(98)00562-2.
PubMed 9973009Tse HF, Yu C, Wong KK, Tsang V, Leung YL, Ho WY, Lau CP. Functional abnormalities in patients with permanent right ventricular pacing: the effect of sites of electrical stimulation. J Am Coll Cardiol. 2002 Oct 16;40(8):1451-8. doi: 10.1016/s0735-1097(02)02169-1.
PubMed 12392836Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
PubMed 12782566Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.
PubMed 12495391Stambler BS, Ellenbogen K, Zhang X, Porter TR, Xie F, Malik R, Small R, Burke M, Kaplan A, Nair L, Belz M, Fuenzalida C, Gold M, Love C, Sharma A, Silverman R, Sogade F, Van Natta B, Wilkoff BL; ROVA Investigators. Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Nov;14(11):1180-6. doi: 10.1046/j.1540-8167.2003.03216.x.
PubMed 14678131Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12. doi: 10.1016/s0002-9149(96)00718-7.
PubMed 9193029de Cock CC, Meyer A, Kamp O, Visser CA. Hemodynamic benefits of right ventricular outflow tract pacing: comparison with right ventricular apex pacing. Pacing Clin Electrophysiol. 1998 Mar;21(3):536-41. doi: 10.1111/j.1540-8159.1998.tb00095.x.
PubMed 9558684Alboni P, Scarfo S, Fuca G, Mele D, Dinelli M, Paparella N. Short-term hemodynamic effects of DDD pacing from ventricular apex, right ventricular outflow tract and proximal septum. G Ital Cardiol. 1998 Mar;28(3):237-41.
PubMed 9561877Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15.
PubMed 19915220Nielsen, Jens Cosedis - Blomstrom-Lundqvist, Carina. DANPACE: The Danish multicenter randomised trial on single lead atrial versus dual chamber pacing in sick sinus syndrome. ESC Kongress 2010, Stockholm, Session number: 708001 - 70800.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Right Ventricular Septal Pacing to Minimized Right Ventricular Septal Stimulation in Patients With Sick Sinus Syndrome
- ClinicalTrials.gov ID
- NCT01477138
- Acronym / sponsor ID
- VOTE / VOTEPM
- Conditions
- Sick Sinus Syndrome
- Keywords
- Sick Sinus Syndrome, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy, Pacemaker, Artificial, SSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Klinikum NürnbergUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Nov 2011 (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.
Background:
- Potential negative effects of pacing in the RV-apex are well documented
- However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial.
- The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial [DANPACE, ESC 2010, Stockholm].
Aim:
- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS
Inclusion criterion:
-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Exclusion criteria:
- Life expectancy < 2 years
- Age <18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
- Permanent atrial fibrillation
- Heart failure NYHA III and IV, reduced LV-EF <40%
- ICD indication
- Acute coronary syndrome. PCI or CABG <3 months
- Heart transplant
- Placement of septal RV electrode is not possible
Study design:
- Prospective, monocentric, randomized, double-blinded
- Run-in phase: for weeks AAI [R]-DDD [R]
- Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].
- FU: 6 and 12-months
Primary endpoints:
-LV ejection fraction and end-systolic LV volume after 12 months.
Secondary endpoints:
-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.
Statistics/sample size estimation:
In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:
- 90% power/alpha 5%: 84 patients per group
- 80% power/alpha 5%: 63 patients per group
- 10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.
Material
- PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)
- pacing leads: market-released standard active electrodes
- RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
Detailed description
Background:
- Potential negative effects of pacing in the RV-apex are well documented
- Asynchronous ventricular activation
- reduction of systolic and diastolic LV function
- Experimental data: histological changes
- Asymmetric LV hypertrophy and thinning
- However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial:
- Acute versus chronic
- Small number of cases, uncontrolled, unblinded,
- Brief periods of observation in the cross-over design (3 months)
- "RVOT" often summarizes different stimulation sites: high RVOT, lateral, septal. Actually only limited data with proven septal stimulation
- No objective performance assessment (CPX)
- Assessment of alternative stimulation site previously RVOT versus RV-apex,
- ventricular pacing compared to ventricular pacing, then tested a potential harm to another
- The question of the optimal pacing mode of patients with SSS (DDDR versus AAIR) appears to be open again. While in Germany, two-chamber systems with AAI [R] mode with ventricular back-up are used, should the DDD (R) mode with an AV delay ≤ 220 ms be the preferred pacing mode, according to the results of the DANPACE trial for patients with SSS [DANPACE, ESC 2010, Stockholm].
Aim:
- to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS
Inclusion criterion:
-Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Exclusion criteria:
- Life expectancy < 2 years
- Age <18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
- Permanent atrial fibrillation
- Heart failure NYHA III and IV, reduced LV-EF <40%
- ICD indication
- Acute coronary syndrome. PCI or CABG <3 months
- Heart transplant
- Placement of septal RV electrode is not possible
Study design:
- Prospective, monocentric, randomized, double-blinded
- Run-in phase: 4 weeks AAI [R]-DDD [R]
- ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire
- Randomization: two groups 4 weeks (between 3 to 6 weeks) after implant A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R].
- FU: 6 and 12-months
- ECG, Holter-ECG, PM-interrogation, echocardiography, performance diagnostics, CPX, QoL questionnaire
- Extension of follow-up if possible
Primary endpoints:
-LV ejection fraction and end-systolic LV volume after 12 months.
Secondary endpoints:
-LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months.
Blinding:
- Patient compared to the pacing mode
- Physician: offline analysis of echo and CPX blinded to the pacing mode
Statistics/sample size estimation:
In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months:
- 90% power/alpha 5%: 84 patients per group
- 80% power/alpha 5%: 63 patients per group
- 10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode.
Material
- PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R)
- pacing leads: market-released standard active electrodes (eg. BSCI FineLine 4470 and 4471) Implantation
- Transvenously
- RA-electrode: if possible, short atrial conduction time
- RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDD(R) | – | Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)SSS. PM programmed to DDD(R) mode with ventricular pacing on the right ventricular septum. |
| AAI(R)<=>DDD(R) | – | Procedure: pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)SSS, PM-mode programmed for minimizing right ventricular pacing on the right interventricular septum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with symptomathic sick sinus syndrome
Key inclusion criteria (1 listed)
- Pacemaker indication according to current guidelines: sick sinus syndrome (SSS)
Key exclusion criteria (11 listed)
- Life expectancy <2 years
- Age < 18 years
- Noncompliance with regard to participation in the study
- Pregnancy
- AV block ° 2 and higher
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 |
|---|---|---|
| pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)Also: AAI(R)<=>DDD(R), DDD(R)Indication for pacemaker implantation: sick sinus syndrome in conformity with the current guidelines. Only market-released CE certified 2-chamber cardiac pacemakers and electrodes are used. The implantation is done according to the applicable standards. Active RV-lead is positioned on the right ventricular septum. | Procedure or surgery | AAI(R)<=>DDD(R), DDD(R) |
Primary outcome
end-systolic LV volume
Time frame: at randomisation and after 12 months
left ventricular ejection fraction (LV-EF)
Time frame: at randomisation and after 12 months
TTE, Simpson, biplane
7 secondary outcomes
TAPSE
Time frame: at randomisation and after 12 months
echocardiographic parameter of dyssynchrony
Time frame: at randomisation and after 12 months
peak VO2, VO2 AT, VO2/HR, VE/VCO2 slope
Time frame: at randomisation and after 12 months
quality of life-scores
Time frame: at randomisation and after 12 months
AF burden
Time frame: at randomisation and after 12 months
% ventricular pacing
Time frame: at randomisation and after 12 months
LV end diastolic volume
Time frame: at randomisation and after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Background: PubMed 9973009Schwaab B, Frohlig G, Alexander C, Kindermann M, Hellwig N, Schwerdt H, Kirsch CM, Schieffer H. Influence of right ventricular stimulation site on left ventricular function in atrial synchronous ventricular pacing. J Am Coll Cardiol. 1999 Feb;33(2):317-23. doi: 10.1016/s0735-1097(98)00562-2.
- Background: PubMed 12392836Tse HF, Yu C, Wong KK, Tsang V, Leung YL, Ho WY, Lau CP. Functional abnormalities in patients with permanent right ventricular pacing: the effect of sites of electrical stimulation. J Am Coll Cardiol. 2002 Oct 16;40(8):1451-8. doi: 10.1016/s0735-1097(02)02169-1.
- Background: PubMed 12782566Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
- Background: PubMed 12495391Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.
- Background: PubMed 14678131Stambler BS, Ellenbogen K, Zhang X, Porter TR, Xie F, Malik R, Small R, Burke M, Kaplan A, Nair L, Belz M, Fuenzalida C, Gold M, Love C, Sharma A, Silverman R, Sogade F, Van Natta B, Wilkoff BL; ROVA Investigators. Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Nov;14(11):1180-6. doi: 10.1046/j.1540-8167.2003.03216.x.
- Background: PubMed 9193029Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12. doi: 10.1016/s0002-9149(96)00718-7.
- Background: PubMed 9558684de Cock CC, Meyer A, Kamp O, Visser CA. Hemodynamic benefits of right ventricular outflow tract pacing: comparison with right ventricular apex pacing. Pacing Clin Electrophysiol. 1998 Mar;21(3):536-41. doi: 10.1111/j.1540-8159.1998.tb00095.x.
- Background: PubMed 9561877Alboni P, Scarfo S, Fuca G, Mele D, Dinelli M, Paparella N. Short-term hemodynamic effects of DDD pacing from ventricular apex, right ventricular outflow tract and proximal septum. G Ital Cardiol. 1998 Mar;28(3):237-41.
- Background: PubMed 19915220Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15.
- Results publicationNielsen, Jens Cosedis - Blomstrom-Lundqvist, Carina. DANPACE: The Danish multicenter randomised trial on single lead atrial versus dual chamber pacing in sick sinus syndrome. ESC Kongress 2010, Stockholm, Session number: 708001 - 70800.
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Bradyarrhythmias, AV Block Complete
Recruiting
LEAP 2 Chronic EFS
Cardiac Pacemaker, Cardiac Rhythm Disorder
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
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.
Natalia Rohr contact
Matthias Pauschinger, Prof.Dr.med. study chair
Klinikum Nuernberg South/ Cardiology
Dirk Bastian, MD principal investigator
Klinikum Nuernberg
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 Sick Sinus Syndrome, run by Klinikum Nürnberg at 1 site in Germany.
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 11 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 22 Nov 2011. 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 Germany. 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 Dirk Bastian, Dr.med (+499113982989, dirk.bastian@klinikum-nuernberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end-systolic LV volume (time frame: at randomisation and after 12 months). 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 NCT01477138, which also lists 10 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 22 Nov 2011.