Condition category
Signs and Symptoms
Date applied
15/04/2010
Date assigned
23/07/2010
Last edited
23/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Flammang

ORCID ID

Contact details

Croix Rousse University Hospital
103 Grand Rue de la Croix Rousse
Lyon
69004
France
+33 (0)472 072865
daniel.flammang@yahoo.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparative study of two types of pacing for the treatment of unexplained syncope (vasovagal syndrome): a multicentre, single-blinded, randomised controlled trial with a direct individual benefit

Acronym

Study hypothesis

To compare the effectiveness of a dual chamber pacing (DDD) at 70 beats per minute (bpm) and a single chamber atrial pacing (AAI) at 30 bpm in patients suffering from vasovagal syndrome related to a predominant cardio-inhibitory reflex determined by adenosine-5'-triphosphate (ATP) test.

Null hypothesis:
The cumulative percentage syncope recurrence in the 30 bpm AAI-mode stimulated group, rp, equals that in the 70 bpm DDD-mode group, rw. Thus, rp=rw=r0.

Alternative hypothesis: rp=arw, where a =/= 1.

Ethics approval

1. The Ethics Committee of Poitiers University approved on the 1st of September 1999 (ref: 99.07.22)
2. Individual ethics committees of each clinical centre

Study design

Prospective multicentre comparative randomised single blind study with a direct individual benefit

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at https://www.healthstudies.umn.edu/trc/en/en_protocol-2002-02-21.pdf (see pg. 15-16)

Condition

Syncope (unknown origin)

Intervention

ATP testing was carried out prior to randomisation. Only patients with block at least 10 seconds in duration were randomised to pacemaker implantation and programming with either:
1. Dual chamber pacing (DDD) at 70 bpm
2. Single chamber atrial pacing (AAI) at 30 bpm
An injection of adenosine triphosphate will be used to screen for cardiac pause.

The implantation is permanent, but the programming was set for the duration of the study to the random assignment. At the end of the study the recommended programming was to the more successful settings in the study, DDD @ 70bpm. The total follow-up was from January 2000 until May 2005.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Recurrence of syncope

Secondary outcome measures

1. Duration of cardiac pause
2. Reprogramming of pacemaker
3. Recurrences after reprogramming

Overall trial start date

01/07/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (greater than or equal to 18 years), agreeing to take part in the study and having signed the informed consent form
2. Patients having presented one or more episodes of syncope or pre-syncope unexplained by the usual screening tests: questionnaire, clinical examination, orthostatic hypotension investigation, biological tests, electrophysiological study (if necessary), echocardiogram (ECG), Holter, exercise test (optional), electroencephalogram (EEG) (optional), and brain scan (optional)
3. Negative sino-carotid massage (SCM)
4. Head-up tilt test conducted according to Appendix B protocol, whatever the result
5. Positive adenosine-5'-triphospate (ATP) test, confirmed by double reading by principal investigator

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 patients (100 per group)

Participant exclusion criteria

1. Syncope etiology revealed by usual screening testings
2. Positive SCM
3. Atrial or ventricular tachyarrhythmia
4. Defibrillator implanted (DAI)
5. Pacemaker previously implanted
6. Patient on waiting list for or having had heart transplantation
7. Sick sinus syndrome, brady-tachy syndrome
8. Atrial fibrillation, paroxysmal or permanent first and second-degree atrio-ventricular block, trifascicular block
9. Ongoing pregnancy. Women of childbearing age should be using reliable contraception.
10. Acute systemic infection or other surgical contra-indication for pacemaker implantation
11. Chronic obstructive bronchopneumopathy
12. Asthma
13. Diabetes

Recruitment start date

01/07/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Belgium, France

Trial participating centre

Croix Rousse University Hospital
Lyon
69004
France

Sponsor information

Organisation

Croix Rousse University Hospital (France)

Sponsor details

Department of Cardiology
103 Grand Rue de la Croix Rousse
Lyon
69004
France
+33 (0)472 072865
daniel.flammang@yahoo.fr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Medtronic, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes