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Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Primary Purpose

Permanent Pacemaker Implantation

Status

Not yet recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

midazolam with fentanyl

About this trial

This is an interventional treatment trial for Permanent Pacemaker Implantation focused on measuring ablation, atrial fibrillation, stroke

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
Age: 18-80 years
Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
Patients who are willing to sign the informed consent.
Patients who are willing to receive the implantation and post-operative follow-up.

Exclusion Criteria:

Persistent or permanent AF
Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min)
Thyroid gland dysfunction
Pregnancy
Malignant tumor
Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
Life expectancy < 12 months
Patients unable or unwilling to cooperate in the study procedures.

Sites / Locations

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ablation

non-ablation

Arm Description

Patients in this group are treated with radio-frequency catheter ablation.

Patients in this group are treated with rate control medications (e.g., beta blocker, calcium channel blocker, and digitalis) and anti-arrhythmic drugs. They also can be treated with DC cardio-version.

Outcomes

Primary Outcome Measures

Recurrence rate of AF/AFL/AT in both groups

recurrence of AF/AFL/AT evaluated using device interrogation

Recurrence rate of AF/AFL/AT in both groups

recurrence of AF/AFL/AT evaluated using device interrogation

Secondary Outcome Measures

Left ventricular ejection fraction

cardiac function evaluated using echocardiography

Left atrial diameter

cardiac function evaluated using echocardiography

Stroke

ischemic and hemorrhagic stroke

Stroke

ischemic and hemorrhagic stroke

Full Information

NCT ID

NCT03401593

First Posted

December 27, 2017

Last Updated

August 28, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03401593

Brief Title

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Official Title

Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients (AF-pacemaker Tx Study)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

June 2028 (Anticipated)

Study Completion Date

June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.

6. Conditions and Keywords

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

Permanent Pacemaker Implantation

Keywords

ablation, atrial fibrillation, stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ablation

Arm Type

Active Comparator

Arm Description

Patients in this group are treated with radio-frequency catheter ablation.

Arm Title

non-ablation

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

midazolam with fentanyl

Intervention Description

Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.

Primary Outcome Measure Information:

Title

Recurrence rate of AF/AFL/AT in both groups

Description

recurrence of AF/AFL/AT evaluated using device interrogation

Time Frame

1 year after randomization

Title

Recurrence rate of AF/AFL/AT in both groups

Description

recurrence of AF/AFL/AT evaluated using device interrogation

Time Frame

6-month follow up to 5 years

Secondary Outcome Measure Information:

Title

Left ventricular ejection fraction

Description

cardiac function evaluated using echocardiography

Time Frame

1 year after randomization

Title

Left atrial diameter

Description

cardiac function evaluated using echocardiography

Time Frame

1 year after randomization

Title

Stroke

Description

ischemic and hemorrhagic stroke

Time Frame

at least 1 year after randomization

Title

Stroke

Description

ischemic and hemorrhagic stroke

Time Frame

6-month follow up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). Age: 18-80 years Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation Estimated percentage of atrial pacing >40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate) Estimated percentage of ventricular pacing >40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate) Patients who are willing to sign the informed consent. Patients who are willing to receive the implantation and post-operative follow-up. Exclusion Criteria: Persistent or permanent AF Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr > 3.5 mg/dl or Ccr < 30ml/min) Thyroid gland dysfunction Pregnancy Malignant tumor Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) Life expectancy < 12 months Patients unable or unwilling to cooperate in the study procedures.

Facility Information:

Facility Name

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boyoung Joung, MD, Ph.D

Phone

82-2-2228-8460

cby6908@yuhs.ac

12. IPD Sharing Statement

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Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

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