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Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome. (DANPACEII)

Primary Purpose

Sinus Node Disease, Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

DDDR-60

DDD-40

About this trial

This is an interventional treatment trial for Sinus Node Disease focused on measuring Sinus node disease, Atrial fibrillation, Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF.
Age ≥18 years.
Patient informed consent.

Exclusion Criteria:

Permanent or persisting (>7 days) AF prior to implantation.
Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring).
Life expectancy <2 years.
Participation in another interventional research study.
Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
Pregnancy.

Sites / Locations

Department of Cardiology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

DDDR-60

DDD-40

Arm Description

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

DDD, lower pacing rate 40 bpm, RR function off

Outcomes

Primary Outcome Measures

Time to first episode of AF>6 min detected by the pacemaker

First episode of AF > 6 min detected by the device

Secondary Outcome Measures

Time to first episode of AF>6 hours detected by the pacemaker

First episode of AF > 6 hours detected by the device

Time to first episode of AF>24 hours detected by the pacemaker

First episode of AF > 24 hours detected by the device

Time to direct current (DC) cardioversion or medical cardioversion for AF

Time to stroke, transient ischemic attack (TIA), or thromboembolic event

Time to death

Time to all cause death

QOL

Quality of life assessment with SF-36

6MHWT

6-minute hall walk test

Time to need for reprogramming of the pacing rate (cross-over)

Full Information

NCT ID

NCT02034526

First Posted

January 10, 2014

Last Updated

June 19, 2023

Sponsor

Aarhus University Hospital

Collaborators

Aalborg University Hospital, Herning Hospital, Regionshospitalet Viborg, Skive, Aabenraa Hospital, Hospital of South West Jutland, Vejle Hospital, Odense University Hospital, Zealand University Hospital, Rigshospitalet, Denmark, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02034526

Brief Title

Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

Acronym

DANPACEII

Official Title

A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aarhus University Hospital

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF. The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinus Node Disease, Atrial Fibrillation

Keywords

Sinus node disease, Atrial fibrillation, Pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DDDR-60

Arm Type

Placebo Comparator

Arm Description

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Arm Title

DDD-40

Arm Type

Experimental

Arm Description

DDD, lower pacing rate 40 bpm, RR function off

Intervention Type

Device

Intervention Name(s)

DDDR-60

Intervention Description

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Intervention Type

Device

Intervention Name(s)

DDD-40

Intervention Description

DDD, lower pacing rate 40 bpm, RR function off

Primary Outcome Measure Information:

Title

Time to first episode of AF>6 min detected by the pacemaker

Description

First episode of AF > 6 min detected by the device

Time Frame

Within two years

Secondary Outcome Measure Information:

Title

Time to first episode of AF>6 hours detected by the pacemaker

Description

First episode of AF > 6 hours detected by the device

Time Frame

Within two years

Title

Time to first episode of AF>24 hours detected by the pacemaker

Description

First episode of AF > 24 hours detected by the device

Time Frame

Within two years

Title

Time to direct current (DC) cardioversion or medical cardioversion for AF

Description

Time to direct current (DC) cardioversion or medical cardioversion for AF

Time Frame

Within two years

Title

Time to stroke, transient ischemic attack (TIA), or thromboembolic event

Description

Time to stroke, transient ischemic attack (TIA), or thromboembolic event

Time Frame

Within two years

Title

Time to death

Description

Time to all cause death

Time Frame

Within two years

Title

QOL

Description

Quality of life assessment with SF-36

Time Frame

After 12 months

Title

6MHWT

Description

6-minute hall walk test

Time Frame

After 12 months

Title

Time to need for reprogramming of the pacing rate (cross-over)

Description

Time to need for reprogramming of the pacing rate (cross-over)

Time Frame

Within 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF. Age ≥18 years. Patient informed consent. Exclusion Criteria: Permanent or persisting (>7 days) AF prior to implantation. Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring). Life expectancy <2 years. Participation in another interventional research study. Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT). Pregnancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens C Nielsen, prof., DMSc,

Organizational Affiliation

Department of Cardiology, Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Cardiology, Aarhus University Hospital

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

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Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

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