Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/09/2011
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

Mrs Jane Eldridge

ORCID ID

Contact details

Cardiac Catheter Lab
Hemel Hempstead General Hospital
Hillfield Road
Hemel Hempstead
HP2 4AD
United Kingdom
+44 01442 287364
jane.eldridge@whht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0143162643

Study information

Scientific title

Acronym

Study hypothesis

Comparison of pacing modes AA1safe(R) R and DDD(R) in patients with Sick Sinus Syndrome.

Ethics approval

Ethics approval was received from the local medical ethics committee before trial recruitment began.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Sick Sinus Syndrome

Intervention

Retrospective, randomised, longitudinal study of the percentage ventricular pacing and the evolution of atrial fibrillation when compared to the mode DDD (R) in patients with Sick Sinus Syndrome

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Lower percentage of ventricular pacing and the amount of time spent in atrial fibrillation that occurs with each pacing mode

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/04/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients with Sick Sinus Syndrome

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

15/04/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiac Catheter Lab
Hemel Hempstead
HP2 4AD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Hertfordshire Hospitals Research and Development Consortium (UK), NHS R&D Support Funding

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

No publication intended as of 09/10/2008

Publication citations

Additional files

Editorial Notes